Announcement • Jun 18

Roche Receives FDA Acceptance for Supplemental Biologics License Application For Lunsumio And Polivy Combination For Relapsed Or Refractory Large B-Cell Lymphoma

Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy. The FDA is expected to make a decision on approval by 9 February 2027. The sBLA acceptance is based on results from the phase III SUNMO study. At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination demonstrated a 59% reduction in risk of disease progression or death (progression-free survival [PFS]) compared to MabThera/Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx) (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001) and a three-times longer median PFS at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1). The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines. The incidence of cytokine release syndrome events (CRS) in the Lunsumio VELO plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events. Updated data were presented recently at the American Society of Clinical Oncology Annual Meeting and the European Hematology Association Congress, which showed that with longer follow-up, this treatment combination continued to demonstrate clinical benefit in PFS, particularly in the second-line setting, with no new safety signals. LBCL, composed predominantly of DLBCL, is the most common type of non-Hodgkin lymphoma with more than 18,000 new diagnoses each year in the US. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Because this stage of disease is time-sensitive, delays caused by referral requirements, inpatient coordination, or complex treatment logistics can have meaningful clinical consequences. The potential new Lunsumio VELO and Polivy combination may address this critical access issue by offering treatment options closer to where a patient lives. Lunsumio is part of Roche’s industry-leading CD20xCD3 bispecific antibody programme. It is designed with the unique needs and preferences of patients in mind, offering the possibility of outpatient treatment and flexibility between intravenous (IV) and subcutaneous administration routes. Lunsumio IV and Lunsumio VELO are approved for people with third-line or later follicular lymphoma (FL). Lunsumio holds the most extensive long-term data for any bispecific antibody in lymphoma. Ongoing development of Lunsumio in combination with other treatments includes the phase III CELESTIMO and MorningLyte studies in second-line or later and frontline FL, respectively. The SUNMO study [NCT05171647] is a phase III, randomised, open-label, multicentre trial evaluating the efficacy and safety of Lunsumio VELO (mosunetuzumab) in combination with intravenously administered Polivy (polatuzumab vedotin) versus MabThera/Rituxan (rituximab) plus gemcitabine and oxaliplatin in patients with relapsed or refractory large B-cell lymphoma who have received at least one prior systemic therapy and are ineligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes. Large B-cell lymphomas, composed predominantly of diffuse large B-cell lymphoma (DLBCL), are the most common type of non-Hodgkin lymphoma (NHL) that affect B-cell lymphocytes, a type of white blood cell. DLBCL is a highly aggressive and life-threatening disease. While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. While existing intensive standard-of-care treatments exist, structural, geographical, and clinical access barriers mean that many patients — particularly those in rural communities or receiving care outside of specialised academic transplant centres — face significant burdens and inequities in obtaining timely treatment. Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate malignant B cells. Lunsumio is currently approved as a fixed-duration monotherapy for the treatment of adult patients with third-line or later relapsed or refractory follicular lymphoma (FL) in both intravenous and subcutaneous (Lunsumio VELO) formulations. A robust, global development programme is ongoing to explore the clinical utility of Lunsumio earlier in the disease course and in novel combinations, including the phase III CELESTIMO trial in second-line or later FL. Polivy is a first-in-class antibody-drug conjugate (ADC) targeted against CD79b, a protein preferentially expressed on the surface of mature B cells. Polivy binds to CD79b on the lymphoma cells and delivers a cytotoxic chemotherapy agent directly into the cell, inducing cell death via apoptosis while minimising damage to healthy tissue. Polivy is widely approved globally in combination with MabThera/Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone for previously untreated (first-line) diffuse large B-cell lymphoma (DLBCL), as well as in combination with bendamustine and MabThera/Rituxan for relapsed or refractory DLBCL.

Announcement • May 02

+ 1 more update

Roche Showcases Ophthalmology Portfolio At Arvo 2026

Roche announced that it will showcase key real-world, product and pipeline data from its ophthalmology portfolio at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held 3rd to 7th of May in Denver, Colorado, USA. The data being presented emphasise Roche’s focus on preserving vision through innovative therapies, including Vabysmo (faricimab), Susvimo (Port Delivery Platform with ranibizumab) and the investigational interleukin-6 (IL-6) inhibitor, vamikibart. The data cover five retinal conditions including geographic atrophy (GA), retinal vein occlusion (RVO) and uveitic macular edema (UME) as well as diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). New data from the global VOYAGER study (NCT05476926) demonstrate that six months of treatment with Vabysmo dried the retina and improved retinal anatomy in real-world clinical practice. These findings, which utilised a deep learning algorithm to analyse real-world optical coherence tomography images, showed consistent improvements across both treatment-naive patients and those previously treated with other anti-VEGF therapies. Roche will present more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions. Roche will present important new findings from across its ophthalmology portfolio. This includes data exploring the use of Vabysmo in RVO, reinforcing its real-world effectiveness in this patient population. Additionally, new data for Susvimo will highlight its ability to provide sustained disease control, and early data from the investigational IL-6 inhibitor, vamikibart, will offer insights for its potential role in targeting underlying retinal inflammation. Vabysmo is the first bispecific antibody approved for the eye. 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. Vabysmo is approved in more than 110 countries around the world, including the United States, Japan, the United Kingdom and the European Union for people with nAMD and DME, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following RVO. Review by other health authorities is ongoing. Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customised formulation of ranibizumab into the eye over time. Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels. The customised formulation of ranibizumab delivered by Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis (ranibizumab injection), which is approved to treat nAMD and other retinal diseases. In the EU, the devices are collectively referred to as Contivue, and have received EU certification. The drug MAA for nAMD is currently under review by the European Medicines Agency (EMA). Vamikibart is an investigational monoclonal antibody that has been specifically engineered for intravitreal (IVT) administration. It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME. In the phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME. Vamikibart was also well tolerated, with no treatment-related serious adverse events reported. Based on the promising phase I DOVETAIL data, Roche initiated the two identical phase III vamikibart studies MEERKAT and SANDCAT. Vamikibart is being investigated in retinal diseases with recognised inflammatory pathways, including in people with UME. Vamikibart has orphan drug designation in the USA and EU. Overview of key presentations featuring Roche medicines: Vabysmo Anatomical outcomes of faricimab in patients with diabetic macular edema: 6-month real-world imaging from the VOYAGER study Poster #1964 - 0031 Monday 4 May 2026 3:00-4:45 PM Long-term effectiveness and safety of faricimab in eyes with nAMD: 2-year results from the UK FARWIDE-nAMD study Presentation (10 mins) Tuesday 5 May 2026 1:45-2:00 PM Automated quantification of retinal fluid volume in patients with DME: analysis of faricimab vs aflibercept in YOSEMITE/RHINE Presentation (10 mins) Tuesday 5 May 2026 2:00-2:15 PM Anatomical outcomes of faricimab in patients with neovascular age-related macular degeneration: 6-month real-world imaging from the VOYAGER study Presentation (10 mins) Tuesday 5 May 2026 2:30-2:45 PM Reduction in Subretinal Hyperreflective Material Volume With Faricimab vs Aflibercept 2 mg in Treatment-Naïve nAMD: A TENAYA/LUCERNE Post Hoc Analysis Presentation (10 mins) Tuesday 5 May 2026 2:45-3:00 PM One-year outcomes of faricimab patients with DME from a global, prospective observational study: the VOYAGER study Presentation (10 mins) Tuesday 5 May 2026 5:00-5:15 PM One-year outcomes of faricimab treatment in eyes with nAMD from the global, prospective observational VOYAGER study Presentation (10 mins) Thursday 7 May 2026 1:15-1:30 PM Susvimo Patient preference for the PDS vs intravitreal injections: year 2 results from the phase 3 Pagoda trial in patients with diabetic macular edema (DME) Poster #1979 - 0046 Monday 4 May 2026 3:00-4:45 PM Retinal fluid, thickness, and leakage in PDS-treated study eyes vs intravitreal injection-treated fellow eyes in bilateral DME in the Pagoda trial Poster #1980 - 0047 Monday 4 May 2026 3:00-4:45 PM Model-based pharmacokinetic simulations of the Port Delivery Platform with ranibizumab (PDS) under various real-world clinical scenarios Poster #1981 - 0048 Monday 4 May 2026 3:00-4:45 PM Interim analysis of the Belvedere nAMD study: summary of PDS treatment in eyes with high injection burden Presentation (10 mins) Thursday 7 May 2026 3:00-3:15 PM Vamikibart Efficacy and safety of vamikibart in patients with diabetic macular edema: first results from the phase 2 ALLUVIUM trial Presentation (10 mins) Tuesday 5 May 2026 3:30-3:45 PM Efficacy and safety of vamikibart in combination with ranibizumab in patients with DME: first results from the phase 2 BARDENAS trial Presentation (10 mins) Tuesday 5 May 2026 3:45-4:00 PM.

Total Shareholder Yield	2.7%
Future Dividend Yield	2.8%
Dividend Growth	2.1%
Next dividend pay date	n/a
Ex dividend date	n/a
Dividend per share	n/a
Payout ratio	63%

Segment	Dividend Yield
Company (ROP)	2.6%
Market Bottom 25% (CH)	1.9%
Market Top 25% (CH)	3.7%
Industry Average (Pharmaceuticals)	2.5%
Analyst forecast (ROP) (up to 3 years)	2.8%

Data	Last Updated (UTC time)
Company Analysis	2026/08/20 11:39
End of Day Share Price	2026/08/20 00:00
Earnings	2026/06/30
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
John Staszak	Argus Research Company
Gerhard Schwarz	Baader Helvea Equity Research
Mark Purcell	Barclays

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