Medical devices
Abbott's Cologuard Plus® receives CE Mark for colorectal cancer screening in Europe Cologuard Plus is a noninvasive, stool-based DNA screening test designed to detect both colorectal cancer and advanced precancerous lesions In the pivotal BLUE-C study, Cologuard Plus demonstrated 95% sensitivity for colorectal cancer at 94% specificity in the screened population CE Mark is an important regulatory milestone as Abbott
Oct 20 · 06:00·Abbott
Healthcare · Automotive
Phase III Krascendo 1 results demonstrated divarasib’s superiority over current standard of care, first-generation KRAS G12C inhibitors in previously treated advanced G12C-mutated non-small cell lung cancer
Patient-reported outcomes from phase III lidERA study showed improved efficacy of giredestrant over standard endocrine therapy is achieved without compromising tolerability and health-related quality of life in early-stage breast cancer
Phase III results in Chinese patients with metastatic nasopharyngeal carcinoma demonstrate the potential of Tam-Peli, a next-generation B7-H3-targeted ADC, to deliver robust efficacy with a favourable safety profile in high-unmet-need solid tumours
Basel, 19 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) will present new data, including two late-breaking abstracts, across lung, breast and other cancers at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, held from 23 to 27 October in Madrid.
“Our presentations at ESMO 2026 highlight the depth and impact of Roche’s oncology pipeline, driven by emerging science capable of bringing new treatment benefits across diverse and high-unmet-need cancers,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “From establishing head-to-head superiority with divarasib in KRAS G12C-mutated lung cancer to advancing patient-centered oral SERD therapies like giredestrant and next-generation ADCs such as Tam-Peli, we are committed to delivering medicines that not only extend life, but also seek to improve treatment experience, tolerability and quality of life for people living with cancer.
Divarasib demonstrated superior efficacy and best-in-class potential in KRAS G12C NSCLC
Roche will share phase III Krascendo 1 results, which demonstrated divarasib’s best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancer.
Krascendo 1 is the only global head-to-head trial to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation inhibitors.1
Results for this potential best-in-class, next-generation KRAS G12C-targeted therapy will be presented as a late-breaking abstract during a Presidential Symposium.
Giredestrant data support its potential to become the new standard of care in early-stage and advanced breast cancer
Roche will present new data highlighting the potential role of giredestrant, an investigational, oral, potent next-generation selective oestrogen receptor degrader (SERD) and full antagonist,2 in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, a subtype in which more than 90% of cases are diagnosed at an early-stage (I-III).3-6 Key presentations from early-stage to advanced disease include:
Patient-reported outcomes from the phase III lidERA Breast Cancer trial suggesting that the improved efficacy of giredestrant compared to endocrine therapy is achieved without compromising tolerability or Health-Related Quality of Life.
Exploratory biomarker findings from the evERA Breast Cancer trial of giredestrant in combination with everolimus in ER-positive, HER2-negative advanced breast cancer in the post-cyclin-dependent kinase 4/6 inhibitor setting.
Updated interim results for giredestrant plus inavolisib from the MORPHEUS Breast Cancer trial evaluating giredestrant treatment combinations in ER-positive, HER2-negative locally advanced or metastatic breast cancer.
Data demonstrate the potential of a next generation B7-H3 targeted antibody-drug conjugate (ADC) Tam-Peli (tambotatug pelitecan)
New data will also be presented for Tam-Peli, an investigational next generation B7-H3-targeted ADC designed to deliver high-potency anti-tumour activity while limiting off-target toxicity.7 Tam-Peli is currently being investigated across multiple solid tumour indications:
ESMO data include late-breaking interim phase III results in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma, analyses of interstitial lung disease in patients with advanced solid tumours from phase I/II studies, and phase I efficacy and safety data for Tam-Peli in patients with locally advanced or metastatic NSCLC.
These findings build on the TAISHAN-302 phase III data in second-line small cell lung cancer presented at the World Conference on Lung Cancer in September, where the study met all three specified endpoints of overall survival, progression free survival and objective response rate at its first interim analysis.
Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong, and Macau, and plans to rapidly initiate global trials across multiple tumour types.
Overview of key presentations featuring Roche medicines and molecules:
Medicine or moleculeAbstract titleAbstract number/ presentation details
Lung cancer
DivarasibKrascendo 1: Efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC.#LBA5 Proffered Paper Session
Presidential Symposium II
Sunday 25.10.2026
16:30 - 16:42 CET
DivarasibKrascendo 3: A randomised, phase III trial in progress of divarasib vs immunotherapy or observation in patients with resected, stage II-IIIB, KRAS G12C+ non-small cell lung cancer. #2551 TiP Poster
NSCLC, Early-Stage
Monday 26.10.2026
12:00 – 12:45 CET
Tam-PeliTambotatug pelitecan (YL201): Efficacy and safety in locally advanced/ metastatic NSCLC from a phase I study. #2577 Poster
NSCLC, Locally Advanced
Monday 26.10.2026
12:00 – 12:45 CET
Non-specificImmunogenomic signature associated with ICI-related pneumonitis in non-small-cell lung cancer (NSCLC) patients.#4247 Rapid Oral
Basic Science and Translational Research
Sunday 25.10.2026
09:14 - 09:19 CET
Breast cancer
GiredestrantPatient (pt)-reported outcomes (PROs) from the phase III lidERA Breast Cancer (BC) trial of giredestrant (GIRE) in pts with oestrogen receptor-positive, HER2-negative early BC (ER+, HER2− eBC). #538 Rapid Oral
Breast Cancer, Early-Stage
Friday 23.10.2026
16:20 – 16:25 CEST
GiredestrantRetrospective exploratory biomarker (BM) analyses from evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients with oestrogen receptor-positive, HER2-negative advanced BC (ER+, HER2− aBC) in the post-CDK4/6 inhibitor (I) setting.#2 Rapid Oral
Breast Cancer, Advanced Stage
Saturday 24.10.2026
10:20 – 10:25 CEST
GiredestrantUpdated interim analysis of giredestrant (GIRE) + inavolisib (INAVO) in MORPHEUS Breast Cancer (BC): A phase Ib/II study of GIRE treatment (tx) combinations in patients (pts) with oestrogen receptor-positive, HER2-negative locally advanced/metastatic BC (ER+, HER2− LA/mBC).#23 Poster
Advanced Breast Cancer, Other
Saturday 24.10.2026
12:00 – 12:45 CEST
PertuzumabReal-world eligibility for DESTINY-Breast11 (DB-11) neoadjuvant escalation criteria and outcomes of DB-11-eligible vs DB-11-ineligible patients with HER2-positive early breast cancer (HER2+ eBC).#594 Poster
Breast Cancer, Early-Stage
Saturday 24.10.2026
12:00 – 12:45 CEST
ZN-1041BREnnA: Phase II/III randomised study of ZN-A-1041 or tucatinib (TUC), in combination with trastuzumab + capecitabine (HX), in patients with HER2-positive locally advanced or metastatic breast cancer (HER2+LA/mBC) with or without central nervous system (CNS) metastases. #1796 TiP Poster
HER2+ Breast Cancer
Saturday 24.10.2026
12:00 – 12:45 CEST
Solid tumours
Tam-Peli
Tambotatug pelitecan (YL201): Analyses of interstitial lung disease in patients with advanced solid tumours from phase I/II studies. #1057 Poster
Developmental Therapeutics
Friday 23.10.2026
15:15 – 16:00 CEST
YL211 (cMET ADC)Phase I First-in-Human (FIH) Results of YL211, a c-Met targeting Antibody-Drug Conjugate (ADC), in patients (pts) with advanced solid tumors.#1017 Poster
Developmental Therapeutics
Friday 23.10.2026
15:15 – 16:00 CEST
Tam-Peli
Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomised, open-label, phase III study (TAISHAN-301).#LBA43 Proffered Paper Session
Head and Neck Cancer
Sunday 25.10.2026
08:40 - 08:50 CET
Tecentriq (atezolizumab) + Avastin (bevacizumab)Outcomes by baseline tumor burden using 6-and-12 scores and the up-to-7 criteria in TALENTACE: phase III study of on-demand transarterial chemoembolization (TACE) combined with atezolizumab + bevacizumab (Atezo/Bev) or on demand TACE alone in patients with systemically untreated, unresectable hepatocellular carcinoma (uHCC). #1700 ePoster
Hepatocellular Carcinoma
Tecentriq (atezolizumab)ATOMIC (A021502/AIO-KRK-0317): Presentation and outcomes in patients (pts) with stage III d-MMR early-onset colon cancer (EOCC) and average-onset colon cancer (AOCC).#858 Poster
Colon Cancer
Sunday 25.10.2026
12:00 - 12:45 CET
Tecentriq (atezolizumab)Adjuvant atezolizumab in patients with MSI-high/MMR-deficient stage III colorectal cancer ineligible for oxaliplatin-based chemotherapy: the phase II ANTONIO-study (AIO-KRK-0220).#802 Poster
Colon Cancer
Sunday 25.10.2026
12:00 - 12:45 CET
About Roche in Oncology
For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Gadgeel S, et al. P3.12D.07 Divarasib Versus Adagrasib or Sotorasib in Pretreated KRAS G12C+ Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). J of Thorac Oncol. 2024; 19 (10, Supplement): S349.
[2] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.
[3] F. Hoffmann‑La Roche Ltd. (2026) SEER Explorer All BCa by Stage. Data on file.
[4] F. Hoffmann‑La Roche Ltd. (2026) Stage Distribution. Data on file.
[5] F. Hoffmann‑La Roche Ltd. (2026) KREBS and TRM. Data on file.
[6] F. Hoffmann‑La Roche Ltd. (2026). UK_CRUK_EDHub_IncidenceByStageRCRD_DataTable2026-01-08. Data on file.
[7] Xu J, et al. Cancer Res. 2023;83:6304.
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
Phone: +41 79 961 92 50
Irène Stephan
Phone: +41 79 377 83 75Albert Thottiyil
Phone: +41 79 775 66 12
Roche Investor Relations
Dr Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.comDr Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Attachment
Media&Investor Release Roche ESMO 2026 English
Oct 19 · 05:00·Roche
AI · Healthcare
FDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile, regardless of TED activity or duration1,2
Enspryng (satralizumab) represents an important advance for people with TED, offering the first at-home SC treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered1
Enspryng is an anti-IL-6R mAb using novel recycling antibody technology designed to inhibit IL-6 signalling upstream of autoantibody-driven pathology2,3
TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US that can lead to facial disfigurement and vision-threatening complications if left untreated3-7
Basel, 16 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab) for the treatment of adults with thyroid eye disease (TED), providing patients with the first and only at-home subcutaneous treatment option. Enspryng can be administered by a person living with TED or a caregiver following training from a healthcare provider.1
“Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.”
"Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, MD, Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania. “As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies. Enspryng has the potential to meaningfully expand our therapeutic options for patients with thyroid eye disease."
The totality of data from the pivotal Phase III SatraGO programme (SatraGO-1 and SatraGO-2) provided clinically meaningful improvements in patients with TED.1,2 While SatraGO-1 did not meet its pre-specified primary efficacy endpoint at Week 24, SatraGO-2 achieved significant and clinically meaningful difference in proptosis response (52.9% in the Enspryng group compared to 23.4% in the placebo group) and in diplopia reduction (60.7% in the Enspryng group compared to 25.8% in the placebo group) in the active TED population.1,2 Consistent results were achieved in the overall population (including both active and chronic patients) in SatraGO-2.1,2 No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder (NMOSD).1,2 Full results were shared at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.2
“Thyroid eye disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life,” said Christine Gustafson, Chief Executive Officer of the TED Community Organization. “Until now, our community has had very limited choices. The approval of Enspryng represents a critical turning point through a convenient, targeted option.”
The approval in TED, following a priority review designation, marks the second indication for Enspryng, following an approval in neuromyelitis optica spectrum disorder (NMOSD) in 2020.1,8,9 This follows a recent acceptance by the FDA for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).10 Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling.
About SatraGO-1 and -2
SatraGO-1 (NCT05987423) and -2 (NCT06106828) are identically designed, Phase III, randomised, placebo-controlled, multicentre studies to determine the efficacy, durability and tolerability of Enspryng for the treatment of adults with active, moderate‑to‑severe TED and chronic TED. The studies enrolled a total of 258 patients from 19 countries. Participants were randomised 1:1 to receive Enspryng or placebo. The primary endpoints were the proportion of participants with active, moderate-to-severe TED who achieved an at least 2 mm reduction in proptosis in the study eye from baseline at week 24.2,3
About thyroid eye disease (TED)
TED, also known as Graves’ ophthalmopathy, is a complex inflammatory autoimmune disease, affecting the area around the eyes and the eyes themselves, that can be sight-threatening, debilitating and disfiguring.4,5 The most common symptoms are redness, swelling of the eyes, eyelid retraction, appearance of a stare, bulging of one or both eyes (proptosis), double vision (diplopia) and pain.4,6
TED is a progressive rare disease that affects approximately 155 people out of every 100,000.3-5,7 It most commonly occurs in people with hyperthyroidism, approximately 50% of whom experience at least mild TED, but it can also affect people with hypothyroidism or normal thyroid function.4,11
Despite existing approved treatments for TED, a medical need remains for therapies that are effective, well-tolerated, and have a convenient route of administration.3
About Enspryng® (satralizumab)
Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that is designed to bind to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a known key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signalling.1-3,12
Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the European Union and United States, with a well established safety profile in over 16,000 patients.1,13
Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including autoimmune encephalitis (AIE) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The FDA granted priority review of the Enspryng supplemental Biologics License Application (sBLA) for MOGAD in September 2026 with an approval decision expected in January 2027.10
Enspryng has orphan drug designation in the United States and European Union for NMOSD and MOGAD and in the United States for anti-NMDA receptor autoimmune encephalitis (anti-NMDAR AIE) and leucine-rich glioma-inactivated 1 autoimmune encephalitis (LGI1 AIE).
About Roche in Ophthalmology
At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care.
Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Enspryng (satralizumab) Prescribing Information.
[2] Briceño C, et al. Primary Results of the Phase 3 SatraGO-1 and SatraGO-2 Trials: Efficacy and Safety of Satralizumab in Thyroid Eye Disease. Presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium, October 16–17, 2025.
[3] Ezra D, Collins A, Haskova Z, et al. Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. Ophthalmol Ther. 2025;14(12):3119-3132. doi:10.1007/s40123-025-01255-3
[4] McAlinden C. An overview of thyroid eye disease. Eye Vis (Lond). 2014;1:9. doi:10.1186/s40662-014-0009-8
[5] Bartalena L, Piantanida E, Gallo D, Lai A, Tanda ML. Epidemiology, Natural History, Risk Factors, and Prevention of Graves' Orbitopathy. Front Endocrinol (Lausanne). 2020;11:615993. doi:10.3389/fendo.2020.615993
[6] Thyroid eye disease. British Thyroid Foundation. Accessed October 12, 2026. https://www.btf-thyroid.org/thyroid-eye-disease-leaflet
[7] Moledina M, Damato EM, Lee V. The changing landscape of thyroid eye disease: current clinical advances and future outlook. Eye (Lond). 2024;38(8):1425-1437. doi:10.1038/s41433-024-02967-9
[8] FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED). Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2026-06-30
[9] FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD). Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2020-08-17
[10] U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments. Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2026-09-10
[11] Bahn RS. Emerging pharmacotherapy for treatment of Graves' disease. Expert Rev Clin Pharmacol. 2012;5(6):605-607. doi:10.1586/ecp.12.54
[12] Heo YA. Satralizumab: First Approval. Drugs. 2020;80(14):1477-1482. doi:10.1007/s40265-020-01380-2
[13] Enspryng (satralizumab) Summary of Product Characteristics. Accessed October 12, 2026. https://www.ema.europa.eu/en/documents/product-information/enspryng-epar-product-information_en.pdf
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
Phone: +41 79 961 92 50
Irène Stephan
Phone: +41 79 377 83 75Albert Thottiyil
Phone: +41 79 775 66 12
Roche Investor Relations
Dr Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.comDr Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
Investor Relations North America
Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com
Attachment
Media & investor Release Enspryng TED FDA English
Oct 16 · 05:00·Roche
Finance · Healthcare
Stryker (NYSE: SYK), a global leader in medical technologies, announced today that Sonopet 3, its latest ultrasonic bone and soft tissue removal...
Oct 14 · 13:03·Stryker
AI · Healthcare
In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeks1,2
UME is the leading cause of moderate and severe vision loss in patients with uveitis, posing a significant risk of blindness if left untreated3,4
The FDA has accepted Roche's Biologics License Application (BLA), with an approval decision expected by July 2027
Basel, 10 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new one-year data from the Phase III MEERKAT and SANDCAT studies evaluating investigational vamikibart compared with a sham procedure that mimics intravitreal (IVT) injections in adults with uveitic macular edema (UME). Across both studies, data continue to support the potential for rapid and sustained improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment. The data were presented at the American Academy of Ophthalmology 2026 Annual Meeting (AAO 2026) in New Orleans, LA.1
Additionally, the U.S. Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) for vamikibart for the treatment of UME. The filing acceptance is based on the results from the MEERKAT and SANDCAT studies. The FDA is expected to make a decision on approval by July 2027. If approved, vamikibart would be the first non-steroid targeted treatment for UME, with potential to establish a new standard of care. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.
“These one-year results strengthen vamikibart’s clinical profile, confirming that initial visual and anatomical improvements are maintained over 52 weeks,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The acceptance of our application by the FDA and other regulatory bodies around the world brings us closer to offering a transformative, non-steroid therapy for people living with this sight-threatening condition.”
“Currently, UME is commonly treated with off-label therapies or ocular steroids, the latter carrying significant long-term side effects like glaucoma and cataract formation,” said Nisha Acharya, M.D., M.S., Distinguished Professor of Ophthalmology at UCSF and Director of the Uveitis and Ocular Inflammatory Disease Service. “Vamikibart is the first non-steroid targeted therapy to demonstrate meaningful and sustained visual and anatomical improvements in people with UME, offering a potential new treatment option that directly targets the inflammation driving this sight-threatening condition.”
The 16-week primary analysis results were presented at the AAO meeting in October 2025.2 In both MEERKAT and SANDCAT at 52 weeks, a numerically higher proportion of vamikibart-treated patients achieved vision gains compared to sham treatment on the primary endpoint. Key secondary endpoints showed this benefit was maintained, with sustained improvements in average change from baseline in best corrected visual acuity (BCVA) and average change from baseline in central subfield thickness (CST), a key measure of macular edema. Vamikibart demonstrated durable clinical benefit with a low treatment burden: approximately two-thirds of eligible patients required no retreatment after 16 weeks, while the majority of those who did required only one additional injection. Vamikibart was well tolerated, maintaining a favourable safety profile, with a low incidence of treatment-related ocular adverse events (AEs) and intraocular inflammation (IOI) events.1
UME is the leading cause of moderate-to-severe vision loss in individuals with uveitis, predominantly affecting working-age adults.3,4 Approximately 20% of UME patients progress to sustained blindness within three years of diagnosis.5 Standard-of-care treatments, primarily high-dose or local corticosteroids, carry substantial long-term risks, including secondary cataracts and elevated intraocular pressure leading to glaucoma.6-11 As a targeted anti-IL-6 monoclonal antibody, vamikibart is being developed to address these clinical unmet needs and deliver sustained visual preservation.1,12
About the MEERKAT and SANDCAT studies
MEERKAT (NCT05642312) and SANDCAT (NCT05642325) are identical Phase III, global, parallel, multicentre, randomised, double-masked, sham comparator-controlled, 52-week trials of intravitreal (IVT) vamikibart in uveitic macular edema (UME). In both trials, patients were randomised and received treatment every four weeks with either 0.25 mg vamikibart, 1 mg vamikibart or sham IVT injection, for up to 16 weeks, followed by PRN treatment through week 52. The primary endpoint of both Phase III trials was the proportion of participants with a 15 letter or more improvement from baseline in best corrected visual acuity (BCVA) at week 16. Key secondary endpoints included the average change from baseline in BCVA and CST at week 16. The safety of vamikibart was assessed through adverse events (AEs) such as treatment related ocular AEs, intraocular inflammation (IOI) and retinal occlusive vasculitis. The studies included participants with and without prior IVT treatment history and included patients with history of raised IOP and glaucoma.2,13,14
About uveitic macular edema (UME)
UME is characterised by the buildup of fluid in the macula due to uveitis, an inflammatory eye condition.3 Although rare compared to other eye diseases, UME has a disproportionate impact on vision loss and blindness globally.3,15-20 It is the leading cause of moderate and severe vision loss in people with uveitis, and the most frequent sight threatening complication in uveitis.17-22 Uveitis accounts for 10% to 20% of blindness in the United States and Europe, and up to 25% of blindness in the developing world.23 UME has a significant negative impact on people's quality of life, including physical and mental health, social functioning, and visual function for day-to-day activities such as driving and reading.22,24,25 Steroids, the current standard of care for UME, are associated with significant serious side effects such as increased pressure in the eye, glaucoma and cataracts, and have recognised efficacy limitations.6-11
About vamikibart
Vamikibart is an investigational monoclonal antibody that has been specifically engineered for IVT administration.1,2,12 It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME.1,2,12 In the Phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME.12 Vamikibart was also well tolerated, with no treatment-related serious adverse events reported.12 Based on the promising Phase I DOVETAIL data, Roche initiated the two identical Phase III vamikibart studies MEERKAT and SANDCAT.1,2,12 Vamikibart is being investigated in retinal diseases with recognised inflammatory pathways. Vamikibart has orphan drug designation in the United States and European Union.
About Roche in Ophthalmology
At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care.
Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Acharya N, et al. Vamikibart for Uveitic Macular Edema: Week 52 Efficacy and Safety Results From the Phase 3 MEERKAT and SANDCAT Trials. Presented at: the American Academy of Ophthalmology Annual Meeting (AAO 2026); 2026 October 10; New Orleans, Louisiana, United States.
[2] Khurana RN, et al. Efficacy and Safety of Vamikibart in Patients With Uveitic Macular Edema: First Report of Phase 3 MEERKAT/SANDCAT Trials. Presented at: the American Academy of Ophthalmology Annual Meeting (AAO 2025); 2025 October 17; Orlando, Florida, United States.
[3] Massa H, Pipis SY, Adewoyin T, Vergados A, Patra S, Panos GD. Macular edema associated with non-infectious uveitis: pathophysiology, etiology, prevalence, impact and management challenges. Clin Ophthalmol. 2019;13:1761-1777. doi:10.2147/OPTH.S180580
[4] Jones NP, Pradeep A, John B. Certification of vision impairment in patients with uveitis attending a specialist clinic. Ocul Immunol Inflamm. 2019;27(4):540-544. doi:10.1080/09273948.2018.1441874
[5] Do BK, et al. Visual Outcomes by Age and Sex in Uveitic Macular Edema: Real-World Retina Registry Analysis. Presented at: the 44th Annual Meeting of the American Society of Retinal Specialists; 2026 July 15–18; Montréal, Canada.
[6] Rosenbaum JT, Bodaghi B, Couto C, et al. New observations and emerging ideas in diagnosis and management of non-infectious uveitis: A review. Semin Arthritis Rheum. 2019;49(3):438-445. doi:10.1016/j.semarthrit.2019.06.004
[7] Leandro L, Beare N, Bhan K, et al. Systemic corticosteroid use in UK Uveitis practice: results from the ocular inflammation steroid toxicity risk (OSTRICH) study. Eye. 2021;35(12):3342-3349. doi:10.1038/s41433-020-01336-6
[8] Nguyen QD, Hatef E, Kayen B, et al. A Cross-sectional Study of the Current Treatment Patterns in Noninfectious Uveitis among Specialists in the United States. Ophthalmology. 2011;118(1):184-190. doi:10.1016/j.ophtha.2010.03.029
[9] Fini ME, Schwartz SG, Gao X, et al. Steroid-induced ocular hypertension/glaucoma: Focus on pharmacogenomics and implications for precision medicine. Prog Retin Eye Res. 2017;56:58-83. doi:10.1016/j.preteyeres.2016.09.003
[10] Sen HN, Vitale S, Gangaputra SS, et al. Periocular Corticosteroid Injections in Uveitis: Effects and Complications. Ophthalmology. 2014;121(11):2275-2286. doi:10.1016/j.ophtha.2014.05.021
[11] Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clinical Therapeutics. 2017;39(11):2216-2229. doi:10.1016/j.clinthera.2017.09.011
[12] Sharma S, Lin P, Hu A, et al. Interleukin 6 Inhibition With Vamikibart for Uveitic Macular Edema: The Phase 1 DOVETAIL Nonrandomized Clinical Trial. JAMA Ophthalmol. 2026;144(5):442-451. doi:10.1001/jamaophthalmol.2026.0610
[13] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2025. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05642312
[14] Hoffmann-La Roche. A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema. clinicaltrials.gov; 2026. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT05642325
[15] Teper SJ. Update on the Management of Uveitic Macular Edema. J Clin Med. 2021;10(18):4133. doi:10.3390/jcm10184133
[16] Fardeau C, Champion E, Massamba N, LeHoang P. Uveitic macular edema. Eye. 2016;30(10):1277-1292. doi:10.1038/eye.2016.115
[17] Smith JR, Thorne JE, Flaxel CJ, et al. Treatment of Noninfectious Uveitic Macular Edema with Periocular and Intraocular Corticosteroid Therapies: A Report by the American Academy of Ophthalmology. Ophthalmology. 2024;131(9):1107-1120. doi:10.1016/j.ophtha.2024.02.019
[18] Sood G, Patel BC. Uveitic Macular Edema. In: StatPearls. StatPearls Publishing; 2023. Accessed September 17, 2026. http://www.ncbi.nlm.nih.gov/books/NBK562158/
[19] Tomkins-Netzer O, Lightman SL, Burke AE, et al. Seven-Year Outcomes of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial and Follow-up Study Results. Ophthalmology. 2021;128(5):719-728. doi:10.1016/j.ophtha.2020.08.035
[20] Matas J, Llorenç V, Fonollosa A, et al. Systemic Regulatory T Cells and IL-6 as Prognostic Factors for Anatomical Improvement of Uveitic Macular Edema. Front Immunol. 2020;11:579005. doi:10.3389/fimmu.2020.579005
[21] Tomkins-Netzer O, Talat L, Bar A, et al. Long-Term Clinical Outcome and Causes of Vision Loss in Patients with Uveitis. Ophthalmology. 2014;121(12):2387-2392. doi:10.1016/j.ophtha.2014.07.007
[22] Tallouzi MO, Moore DJ, Bucknall N, et al. Outcomes important to patients with non-infectious posterior segment-involving uveitis: a qualitative study. BMJ Open Ophth. 2020;5(1):e000481. doi:10.1136/bmjophth-2020-000481
[23] Cunningham ET, Zierhut M. Vision Loss in Uveitis. Ocular Immunology and Inflammation. 2021;29(6):1037-1039. doi:10.1080/09273948.2021.2017152
[24] Tomkins-Netzer O, Lightman S, Drye L, et al. Outcome of Treatment of Uveitic Macular Edema: The Multicenter Uveitis Steroid Treatment Trial 2-Year Results. Ophthalmology. 2015;122(11):2351-2359. doi:10.1016/j.ophtha.2015.07.036
[25] Frick KD, Drye LT, Kempen JH, et al. Associations among Visual Acuity and Vision- and Health-Related Quality of Life among Patients in the Multicenter Uveitis Steroid Treatment Trial. Invest Ophthalmol Vis Sci. 2012;53(3):1169. doi:10.1167/iovs.11-8259
Roche Global Media Relations
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Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
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Media Investor Release Vamikibart in UME English
Oct 10 · 21:40·Roche
Healthcare · Automotive
FDA approval is based on results from the landmark phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone1
First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care
Nearly 25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years2,3
Approval marks the twelfth indication for Tecentriq in the US
Basel, 9 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumour characterised by high mutation rates. This approval marks the twelfth indication for Tecentriq in the US.
“This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.”
“Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator for the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death.”
The FDA approval is based on the landmark phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA® MMR RxDx Panel.1 The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6.1
Colon cancer remains one of the world's most common and deadliest tumours.4 Over one million people are diagnosed globally each year, and nearly 25% of all colon cancers are diagnosed at stage III.2-4 Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years.2,3 Approximately 15% of colon cancer patients present with dMMR or microsatellite instability-high (MSI-H) tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.5
Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this immunotherapy-based adjuvant option to patients with dMMR colon cancer worldwide as soon as possible.
About the ATOMIC study
ATOMIC (A021502, NCT02912559) is a phase III, randomised, open-label, multicentre study investigating the addition of Tecentriq® (atezolizumab) to modified (m)FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomised 1:1 to receive either mFOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or mFOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS).
The global study in the US was sponsored by the US National Cancer Institute (NCI), part of the National Institutes of Health, and led by the Alliance for Clinical Trials in Oncology (Alliance) with participation from other NCI-funded National Clinical Trials Network (NCTN) groups. Genentech, a member of the Roche Group, provided support for the study through a Cooperative Research and Development Agreement between NCI and Genentech. The trial was led globally by Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator within the Alliance. German participation in this major international academic collaboration was enabled through close cooperation between the Alliance and the AIO-Studien-gGmbH, in partnership with the AIO (Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society (Deutsche Krebsgesellschaft, DKG), under the national leadership of Prof. Dr. Anke Reinacher-Schick (Ruhr-Universität Bochum). AIO-affiliated study sites enrolled patients during the later recruitment phase, ensuring access for eligible patients in Germany.
About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.
About Roche in oncology
For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Sinicrope F, et al. Atezolizumab plus FOLFOX for Stage III Mismatch Repair–Deficient Colon Cancer. N Engl J Med. 2026;394:1155-1166.
[2] Gonzalez B, et al. Analyzing recurrence in colorectal cancer: Is a five years follow-up enough? Annals of Oncology. 2024;35(1);11.
[3] Nors J et al. Incidence of Recurrence and Time to Recurrence in Stage I to III Colorectal Cancer: A Nationwide Danish Cohort Study. JAMA Oncology. 2024;10(1):54–62.
[4] World Health Organization. Cancer [Internet; cited 2026 October]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.
[5] Boland CR, et al. Microsatellite Instability in Colorectal Cancer. Gastroenterology. 2010;138:2073–2087.
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
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Irène Stephan
Phone: +41 79 377 83 75Albert Thottiyil
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Roche Investor Relations
Dr Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.comDr Sabine Borngräber
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Media&Investor Release FDA approval for Tecentriq Tecentriq Hybreza English
Oct 9 · 05:00·Roche
Healthcare · Logistics
SAS is recognized by Fast Company for its digital twin technology used by Sterilcentral, Denmark’s largest medical sterilization provider, to optimize the cleaning, logistics planning and delivery of surgical instruments across hospitals.
Oct 6 · 04:00·SAS
Healthcare · Medical devices
Stryker, a global leader in medical technologies, announced the launch of Mako 4 SmartRobotics™ (Mako 4), the fourth generation of Mako, bringing its ...
Oct 5 · 04:30·Stryker
AI · Healthcare
New real-world results for Vabysmo in nAMD, DME and RVO reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals1-3
Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care4,5
With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide1-3
Basel, 1 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo® (faricimab) in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).1-3 Across all study cohorts, results confirm the real-world effectiveness of Vabysmo in line with Phase III trial results, with vision gains and robust anatomical improvements in untreated eyes and stable or improved vision with improved anatomical outcomes in previously treated eyes.1-3
In the nAMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment.1,2 In RVO, both subtypes of the disease showed improvements in efficacy in people treated with Vabysmo.3 In the central/hemi-RVO cohort, vision and CST improved in both previously untreated and treated eyes after six months of Vabysmo therapy.3 In the branch RVO cohort, vision and CST improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after six months of Vabysmo treatment.3 The data are being presented at the EURETINA 2026 Annual Meeting in Vienna, Austria.
“These real-world results underscore how the efficacy and safety observed in our pivotal Vabysmo studies translate directly into routine clinical practice globally,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The sustained visual improvements and meaningful anatomical drying seen in the VOYAGER study reinforce the role of Vabysmo in helping to address important unmet needs for patients with retinal conditions.”
“In daily clinical practice, we manage diverse patient populations with complex treatment histories who don’t always mirror the strict entry criteria of controlled Phase III trials.” said Professor Robyn Guymer, Chair of the VOYAGER Steering Committee and Deputy Director of the Centre for Eye Research Australia. “The latest VOYAGER data give physicians from across the world the confidence that Vabysmo delivers sustained visual gains, meaningful anatomical drying, and an established safety profile in everyday practice – whether a patient is starting treatment for the first time or transitioning from another therapy.”
The new VOYAGER real-world data in nAMD, DME and RVO are consistent with previous Phase III study results and demonstrate the effectiveness, durability and safety of Vabysmo across diverse global practices.1-3 Across all cohorts of the study, the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) was consistently reduced in previously untreated and treated eyes.1-3 In the nAMD and DME groups, fewer Vabysmo injections were received during months 7-12 compared with months 1-6, suggesting extension of treatment intervals.1,2
Mean change in visual acuity (VA)
Early Treatment Diabetic Retinopathy Study (ETDRS) lettersMean change in central subfield thickness (CST)
µmPresence of subretinal fluid (SRF)
% of eyesPresence of intraretinal fluid (IRF)
% of eyes
nAMD (after 12 months of Vabysmo treatment)1
No prior treatment+4.6–110.572.1→25.348.5→20.6
Previously treated-0.1-26.161.6→37.935.4→25.0
DME (after 12 months of Vabysmo treatment)2
No prior treatment+8.2-127.826.5→6.887.3→58.1
Previously treated+2.7-71.322.1→9.380.5→68.1
Branch RVO (after 6 months of Vabysmo treatment)3
No prior treatment+10.0-171.336.3→11.883.8→50.0
Previously treated+2.0-59.015.9→6.682.6→80.3
Central/hemi-RVO (after 6 months of Vabysmo treatment)3
No prior treatment+16.6-287.450.7→9.885.7→29.4
Previously treated+3.9-63.414.9→10.389.4→74.4
In VOYAGER, the Vabysmo safety profile was generally consistent with that established in the Phase III studies in nAMD, DME and RVO.1-3
About VOYAGER
VOYAGER is the largest global, prospective, non-interventional real-world study of Vabysmo (faricimab).1-3 It captures real-world data from 28 countries/regions across six continents representing more than 5,000 patients treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) or retinal vein occlusion (RVO).1-3 The study leverages state-of-the-art AI and deep learning algorithms to evaluate SD-OCT images captured during routine clinical practice.4-6
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.7-9 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.9,10 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO).7,8,11-14 Review by other health authorities is ongoing.
About Roche in Ophthalmology
At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care.
Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Guymer R, et al. One-year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With nAMD From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[2] Sheth V, et al. One–Year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With DME From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[3] Hattenbach L-O, et al. Real-World Clinical and Anatomical Outcomes With Faricimab in Patients With Retinal Vein Occlusion From a Global, Prospective Observational Study: The VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[4] Bailey C, et al. Anatomical Outcomes of Faricimab in Patients with Neovascular Age-Related Macular Degeneration: 12-Month Real-World Imaging from the VOYAGER Study. Presented at:26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[5] Koh A, et al. Anatomical Outcomes of Faricimab in Patients with Diabetic Macular Edema: 12-Month Real-World Imaging from the VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[6] Guymer R, Bailey C, Chaikitmongkol V, et al. Rationale and Design of VOYAGER: Long-term Outcomes of Faricimab and Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Clinical Practice. Ophthalmol Sci. 2024;4(3):100442. doi:10.1016/j.xops.2023.100442.
[7] United States (US) Food and Drug Administration (FDA). Highlights of Prescribing Information, Vabysmo. April 2026. [Internet; cited September 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761235s008lbl.pdf
[8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. May 17, 2022. [Internet; cited September 2026]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative
[9] Heier JS, Khanani AM, Quezada Ruiz C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1.
[10] Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6.
[11] European Medicines Agency. Summary of Product Characteristics, Vabysmo. August 2026. [Internet; cited September 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[12] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[13] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[14] Roche data on file.
Roche Global Media Relations
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Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
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Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
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Attachment
Media Release Vabysmo EURETINA 2026 English
Oct 1 · 06:00·Roche
Healthcare · Food & drink
Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard endocrine therapy plus everolimus1
By targeting resistance to endocrine treatments, the giredestrant combination seeks to delay disease progression and improve overall patient outcomes1
The FDA has set a PDUFA goal date for giredestrant in early-stage breast cancer of 30 November 2026 and in advanced disease of 18 December 2026
Basel, 1 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that detailed results from the evERA Breast Cancer study, showing investigational giredestrant in combination with everolimus significantly improved progression-free survival (PFS) versus standard endocrine therapy plus everolimus, were published in The New England Journal of Medicine (NEJM). The evERA trial is evaluating giredestrant, an investigational oral selective oestrogen receptor degrader (SERD), in combination with everolimus in people with oestrogen receptor (ER)-positive locally advanced or metastatic breast cancer who had disease progression or recurrence following treatment with a cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy.1
“Despite advancements with CDK4/6 inhibitor treatment in the first-line setting, many people with advanced breast cancer will eventually experience disease progression as their tumours become resistant to endocrine therapy,” said Dr Erica L. Mayer, Medical Oncologist at Dana-Farber Cancer Institute. “The evERA trial demonstrated that the giredestrant combination significantly delayed disease progression, potentially offering a promising all-oral treatment option in a setting where there remains a need for additional treatments to improve patient outcomes.”
In the ESR1-mutated population, the median PFS was 10.0 months with giredestrant plus everolimus compared with 5.5 months in the comparator arm (stratified hazard ratio [HR]=0.38, 95% CI: 0.27-0.54, p<0.001).1 In the intent-to-treat (ITT) population, the median PFS was 8.8 months compared with 5.5 months in the giredestrant and comparator arms, respectively (HR=0.56, 95% CI: 0.44-0.71, p<0.001).1 Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00) and ESR1-mutated populations (HR=0.62, 95% CI: 0.38-1.02).1 Follow-up for OS will continue to the next analysis. Adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of the individual medicines.1 No unexpected safety findings were observed, including no photopsia and low rates of bradycardia.1
“The evERA results represent an important step forward for people with ER-positive advanced breast cancer and underscore the potential for giredestrant to help address the challenge of disease progression in this setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Together with the positive phase III lidERA results in early breast cancer, these findings reinforce the potential of giredestrant to redefine care in both metastatic and early disease settings.”
Additional evERA analyses were presented at the 2026 American Society of Clinical Oncology Annual Meeting, showing that giredestrant plus everolimus prolongs PFS2 (time from randomisation to disease progression following second-line therapy) and chemotherapy-free survival compared with standard endocrine therapy, suggesting that the clinical benefit may be sustained beyond initial progression.2
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer accounts for approximately 70% of breast cancer cases.3 Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes.3,4
evERA was the first positive phase III readout for giredestrant, followed by the lidERA Breast Cancer study in the early-stage setting.1,5 Based on these evERA data, the US Food and Drug Administration (FDA) accepted Roche’s New Drug Application (NDA) for giredestrant in combination with everolimus for the treatment of people with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer whose disease has recurred during or after completing endocrine-based adjuvant therapy, or who have progressed on at least one endocrine-based regimen in the metastatic setting. The FDA is expected to decide on the application by 18 December 2026. The FDA also accepted an NDA under Priority Review for giredestrant as an adjuvant treatment for adults with ER-positive, HER2-negative, stage I, II, and III breast cancer based on the lidERA results. The FDA has set a Prescription Drug User Fee Act goal date of 30 November 2026.
Roche’s expanding giredestrant clinical development programme spans distinct treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with HR-positive breast cancer as possible.
About the evERA Breast Cancer study
evERA Breast Cancer [NCT05306340] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard endocrine therapy in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.6
The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomisation to the time when the disease progresses or a patient dies from any cause.6 In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations.7,8 Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.6
About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.9
Giredestrant is designed to block oestrogen from binding to the oestrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.10
Giredestrant has an extensive clinical development programme including five company-sponsored phase III clinical trials to address the needs of patients acrossmultiple treatment settings and lines of therapy:
Giredestrant versus standard endocrine therapy as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)11
Giredestrant plus everolimus versus standard endocrine therapy plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)6
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)12
Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)13
Giredestrant plus Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)14
About hormone receptor (HR)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year.15 Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.16
HR-positive, human epidermal growth factor receptor 2-negative breast cancer accounts for approximately 70% of breast cancer cases and the majority are diagnosed in the early-stage.3 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to hormones like oestrogen, which can contribute to tumour growth.17
Despite treatment advances, HR-positive breast cancer remains particularly challenging to treat due to its biological complexity.18 Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.18,19 There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.18,19
About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes.
By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Mayer E, et al. Giredestrant plus Everolimus in Advanced Breast Cancer. NEJM; 2026 October. DOI:10.1056/NEJMoa2602457.
[2] Jhaveri K, et al. Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor–positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i). Presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; 2026 May 29 – June 02; Chicago, Illinois, US. #1016.
[3] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.
[4] Sahin T, et al. Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer. Cancer Treatment Reviews. 2025 April;135:102924.
[5] Bardia A, et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global Phase III lidERA Breast Cancer trial. Presented at: San Antonio Breast Cancer Symposium (SABCS); 2025 December 9-12; San Antonio, Texas, United States. #GS1-10.
[6] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT05306340.
[7] Meisel J L, et al. Real-world estrogen receptor 1 (ESR1) testing patterns and results in U.S. patients with metastatic breast cancer, 2018-2024. JCO Oncol Pract. 2025;21:579.
[8] Chaudhary N, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. npj Breast Cancer. 2024;10,15.
[9] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: The ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.
[10] Metcalfe C, et al. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Presented at: SABCS; 2018 December 4-8; San Antonio, Texas, USA. Abstract #P5-04-07.
[11] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT04961996.
[12] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT04546009.
[13] ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT06065748.
[14] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) [Internet; cited 2026 September]. Available from: https://clinicaltrials.gov/study/NCT05296798.
[15] World Health Organization. Breast Cancer [Internet; cited 2026 September]. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.
[16] World Health Organization. Cancer Today [Internet; cited 2026 September]. Available from: https://gco.iarc.fr/today/en/dataviz/bars?mode=cancer&types=1&group_populations=1&sexes=2&key=asr&age_end=14.
[17] National Cancer Institute. Hormone Therapy for Breast Cancer [Internet; cited 2026 September]. Available from: https://www.cancer.gov/types/breast/breast-hormone-therapy-fact-sheet.
[18] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020 Apr 13;37(4):496–513.
[19] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018 Feb;63:144-55.
Roche Global Media Relations
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Simon Goldsborough
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Attachment
20261001 evERA phase III NEJM
Oct 1 · 05:00·Roche
Healthcare · Food & drink
Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in delaying disability1
Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a Phase III PPMS trial (FENtrepid), with numerical benefit vs Ocrevus2
Fenebrutinib is designed to address two drivers of MS – acute inflammation causing relapses and chronic brain inflammation driving disability progression1,2
If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS, offering a new option for the nearly 1 million Americans living with MS3
Basel, 30 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The filing acceptance is based on data from the comprehensive clinical programme, including the Phase III FENhance 1 and 2 RMS studies and the Phase III FENtrepid PPMS study.1,2
"People living with multiple sclerosis need treatments that go beyond controlling relapses to help preserve function and independence as the disease progresses," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Three Phase III studies have demonstrated the potential for fenebrutinib to address both relapsing and progressive disease, thereby bringing us closer to an oral treatment that could make a meaningful difference across the MS spectrum."
“Ocrevus transformed how we treat MS, helping more than 525,000 people live a life less defined by their disease. Yet, over a third of all people with MS still receive lower-efficacy treatment,” said Teresa Graham, Roche’s Chief Executive Officer, Pharma. “If approved, fenebrutinib could open a new chapter as the first high-efficacy oral therapy for both relapsing and primary progressive MS, helping to control disease activity while giving people more flexibility and choice.”
Concurrently addressing the life-disrupting relapses and long-term disease progression – the slow, steady loss of physical and mental abilities over time – remains one of the greatest challenges in MS.4 Fenebrutinib is designed to act throughout the body and to cross the blood-brain barrier into the central nervous system to target both the acute inflammation that causes relapses and the chronic inflammation that is thought to drive disability progression.1,2
The NDA for fenebrutinib is supported by three positive Phase III studies:
The FENhance 1 and 2 RMS studies showed that fenebrutinib significantly reduced relapses and both active and chronic brain lesions compared with standard of care, teriflunomide. Fenebrutinib reduced the annualised relapse rate (ARR) by 51.1% (p<0.001) in FENhance 1 and 58.5% (p<0.00001) in FENhance 2 compared with teriflunomide over 96 weeks. This equates to patients having approximately one relapse every 17 years, which is the lowest relapse rate seen in Phase III MS studies. In addition, measures of disability progression, including 12-week composite confirmed disability progression (cCDP12), showed consistent positive trends favouring fenebrutinib over teriflunomide.1
The FENtrepid PPMS study showed fenebrutinib met its primary endpoint of non-inferiority compared with Ocrevus® (ocrelizumab), the current standard of care and only approved medicine for PPMS, in reducing disability progression. Fenebrutinib numerically reduced the risk of progression by 12% compared to Ocrevus, as measured by the time to onset of cCDP12 (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.75, 1.03), with curves separating as early as 24 weeks. A consistent treatment effect on disability progression was observed across patient subgroups, including those without active inflammation, and for the entire treatment duration after 24 weeks.2
The overall rate of serious adverse events for fenebrutinib and teriflunomide, respectively, was 9% and 9% in FENhance 1 and 11% and 6% in FENhance 2. The overall rate of serious adverse events in FENtrepid was 19% for fenebrutinib and 19% for Ocrevus. Liver enzyme elevations were comparable between the fenebrutinib and teriflunomide arms in the RMS studies and observed more often with fenebrutinib compared to Ocrevus in the PPMS study. While an imbalance in reported fatalities was observed across the three pivotal studies, the deaths occurred at different timepoints and had various causes.1,2 Overall, fenebrutinib has shown a manageable safety profile across the three Phase III trials and earlier studies, with a large safety database including more than 2,700 study participants.1,2,5
About fenebrutinib
Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression.
While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme.
About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 3 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.
Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus®, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS.
About Roche in Neurology
Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally.
Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Oh J, et al. Efficacy and Safety of Fenebrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results of the FENhance 1 and 2 Studies. Presented at: 2026 American Academy of Neurology (AAN) Annual Meeting; April 21, 2026; Chicago, IL, USA, and virtual.
[2] Bar-Or A, et al. Efficacy and Safety of Fenebrutinib vs Ocrelizumab in Primary Progressive Multiple Sclerosis: Primary Results of the Phase III FENtrepid Study. Presented at: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026; February 7, 2026; San Diego, CA, USA, and virtual.
[3] MS International Federation. Atlas of MS. [Internet; cited September 2026]. Available from: https://atlasofms.org/map/global/epidemiology/number-of-people-with-ms
[4] Bittner S, Zipp F. Progression in multiple sclerosis - a long-term problem. Curr Opin Neurol. 2022;35(3):293-298. doi:10.1097/WCO.0000000000001044
[5] Bar-Or A, Dufek M, Budincevic H, et al. Safety and efficacy of fenebrutinib in relapsing multiple sclerosis (FENopta): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial and open-label extension study. Lancet Neurol. 2025;24(8):656-666. doi:10.1016/S1474-4422(25)00174-7
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Attachment
Media & Investor Release Fenebrutinib FDA Filing English
Sep 30 · 05:00·Roche
Biotech & pharma · Medical devices
Roche announced today that the Board of Directors of Roche Holding Ltd has approved to propose Dr. Christophe Weber, former CEO of Takeda Pharmaceuticals, for election to the Board of Directors at Roche’s Annual General Meeting on March 9, 2027.
Roche Chairman Severin Schwan: “I am pleased that we have been able to propose Christophe Weber for election to the Board of Directors. Christophe’s intimate knowledge of the healthcare industry and his broad leadership experience will further strengthen our Board.”
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com
Tristan Schmitz
Phone: +41 79 529 70 35Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +41 79 398 38 53Yvette Petillon
Phone: +41 79 961 92 50
Irène Stephan
Phone: +41 79 377 83 75Albert Thottiyil
Phone: +41 79 775 66 12
Attachment
Media Release Change in BoD English
Sep 23 · 05:00·Roche