Cevostamab

Lunsumio VELO reduces administration time from 2-4 hours to approximately one minuteAvailability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse1,2 Basel, 22 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the phase I/II GO29781 study.1 Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial. “Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.” Lunsumio VELO reduces treatment administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated. “This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr Ian Flinn, MD, PhD, Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.” The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively.1 The median duration of response was 22.4 months (95% CI: 16.8–22.8).1 The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhoea.1 The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15).1 CRS can be severe and life-threatening. Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition. These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorisation of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. Roche continues to advance its bispecific antibody programme in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy® (polatuzumab vedotin) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL. About the GO29781 study The GO29781 [NCT02500407] study is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO™ (mosunetuzumab) was established on the basis of objective response rate and duration of response. About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.3,4 It typically responds well to treatment but is often characterised by periods of remission and relapse.3,4 The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis.2 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.4,5 About Lunsumio VELO™ (mosunetuzumab)Lunsumio VELO is a subcutaneous formulation of mosunetuzumab, a 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 target B cells by releasing cytotoxic proteins into the B cells. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications. About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab administered intravenously), Lunsumio SC/VELO™ (mosunetuzumab administered subcutaneously) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References[1] Roche data on file. [2] Fowler NH, at al. Moving T-Cell Therapies into the Standard of Care for Patients with Relapsed or Refractory Follicular Lymphoma: A Review. Targ Oncol. 2024;19:495–510.[3] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited December 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.[4] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited December 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.[5] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.comDr Sabine BorngräberPhone: +41 61 68-88027e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachment Media Investor Release Lunsumio VELO FDA Approval English

Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx1This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with R/R DLBCL who are not candidates for transplantColumvi in combination with GemOx has now been approved in more than 50 countries worldwide and recommended in international treatment guidelines2-4 Basel, 8 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today three-year follow-up data from the pivotal phase III STARGLO study in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT). After a median follow-up of 35.1 months, overall survival (OS) remained twice as long for people treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) plus GemOx (R-GemOx) (25.5 months versus 12.5 months, respectively [hazard ratio (HR)=0.60, 95% confidence interval (CI): 0.43-0.8]).1 Results were presented at the 67th American Society of Hematology Annual Meeting and Exposition, 6-9 December 2025 in Orlando, Florida, US. Subgroup analyses showed consistent results across clinically relevant subgroups of prior line of therapy and age.1 The greatest efficacy benefit was seen in people who had received one prior line of therapy (second line, 2L), with 54.6% still alive at 36 months follow-up.1 For these patients, median OS was not reached with Columvi in combination with GemOx versus 14.4 months (HR=0.58; 95% CI: 0.38-0.89) in the R-GemOx arm.1 Median progression-free survival (PFS) was 20.4 versus 5.5 months (HR=0.41; 95% CI: 0.25-0.65).1 In patients with 2L DLBCL with early relapse (within 12 months), who are typically harder to treat, the complete response rate was 56.0% and the 36 month OS rate was 46.1%.5 “At three years, we see flattening of the overall survival curve, suggesting the possibility of cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at the Mass General Brigham Cancer Institute, US, and principal investigator of the STARGLO study. “These data continue to underscore the meaningful benefit of Glofitamab plus GemOx for patients after initial relapse, when fast and effective treatment is critical given the aggressive nature of this disease.” “By prolonging survival, this Columvi combination could offer people with relapsed or refractory DLBCL long-term remission, and potential additional time to spend with their loved ones without signs of disease or the need for continuous therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The potential of Columvi in combination with GemOx continues to be recognised globally, with approvals in more than 50 countries around the world and inclusion in multiple international treatment guidelines.” Data add to the growing body of evidence supporting the value that this Columvi-based combination can bring to people with 2L+ DLBCL who are not candidates for ASCT or who face barriers accessing other treatment options. As an off-the-shelf and fixed-duration therapy, Columvi plus GemOx can be readily available for infusion in any setting, meaning patients could avoid crucial delays in starting treatment and allowing the possibility of a treatment-free period. The safety profile was unchanged with extended follow up; no new signals were identified, and safety of the combination was consistent with the known safety profiles of the individual medicines. Cytokine release syndrome (CRS) remained the most common adverse event in people treated with Columvi plus GemOx (44.8%; Grade 1: 32.0%, Grade 2: 10.5%, Grade 3: 2.3%).1 Immune recovery in the form of median B-cell and immunoglobulin M count was observed 18-24 months after end-of-treatment.1 Based on the STARGLO data, this Columvi combination is approved in more than 50 countries worldwide, including countries in the EU, the UK, Canada, Australia, China and Mexico, with additional submissions to health authorities ongoing*. Columvi in combination with GemOx is recommended in clinical practice guidelines including the European Society For Medical Oncology, European Hematology Association and the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with category 1 evidence for people with 2L+ DLBCL.†2-4 The US Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Columvi in combination with GemOx for this indication. Roche is continuing to explore the potential of Columvi across other settings including first-line (1L) DLBCL and mantle cell lymphoma (MCL) to elevate treatment standards even further. This includes the phase III SKYGLO study investigating Columvi in combination with Polivy® (polatuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone, in 1L DLBCL, which has recently completed enrolment. In R/R MCL, the phase III GLOBRYTE study evaluating Columvi as a single agent versus investigator’s choice of therapy is currently recruiting. About the STARGLO studyThe STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability. About Columvi® (glofitamab)Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma. About diffuse large B-cell lymphoma (DLBCL)DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.6 Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions.7,8 Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide.8-11 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.12,13 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. *Countries that have approved Columvi in combination with GemOx in R/R DLBCL include: Argentina, Australia, Bahrain, Bosnia and Herzegovina, Canada, China, the European Union, Iceland, Lebanon, Liechtenstein, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Paraguay, Peru, Qatar, South Korea, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay. †NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. References[1] Abramson JS, et al. Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5519.[2] Eyre TA, at al. Lymphomas: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025;36(11):1263-1284.[3] Thieblemont C, et al. Large B-cell lymphoma (LBCL): EHA Clinical Practice Guidelines for diagnosis, treatment, and follow-up. HemaSphere. 2025;9:e70207.[4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.1.2025.[5] Abdulhaq H, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Efficacy and safety in patient subgroups. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3743.[6] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited December 2025]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.[7] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.[8] Budde LE, et al. Characterizing the US Patient Population Receiving Rituximab with Gemcitabine and Oxaliplatin (R-GemOx) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Using Real-World Data. Blood. 2024;144(1):2373.[9] Yamshon, et al. Outcomes of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated With R-GemOx: A Multicenter Cohort Study. Hematol. 2025;100(4):606-615.[10] Sineshaw HM, Zettler CM, Prescott J, et al. Real-world patient characteristics, treatment patterns, and treatment outcomes of patients with diffuse large B-cell lymphoma by line of therapy. Cancer Med. 2024 Apr;13(7):e7173.[11] Koff JL, Larson MC, Martin P et al. LEO Consortium for Real World Evidence (CReWE): Outcomes after Second-Line Therapy in Large B-Cell Lymphoma by Treatment Era. Blood (2023) 142 (Supplement 1): 307.[12] Fabbri N, et al. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312.[13] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr. Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.comDr Sabine BorngräberPhone: +41 61 68-88027e-mail: sabine.borngraeber@roche.com Dr. Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachment Media Investor Release Columvi STARGLO ASH English