Mosunetuzumab

Wednesday, Jun 17, 2026 Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment South San Francisco, CA -- June 17, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous formulation, in combination with Polivy® (polatuzumab vedotin-piiq) 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 February 9, 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 Rituxan® (rituximab), gemcitabine and oxaliplatin (R-GemOx) (hazard ratio 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 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. “Relapsed or refractory large B-cell lymphoma is an aggressive disease thereby representing one of the highest unmet needs in lymphoma care,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “If approved, this Lunsumio/Polivy combination could provide an important chemotherapy-free, outpatient-ready option to help improve outcomes in this setting.” "When treating large B-cell lymphoma, the second-line setting represents a critical window where we must act quickly with effective therapies," said Tara M. Graff, D.O., M.S., Director of Clinical Research at Mission Cancer and Blood. "Current advanced therapies may present complex logistical and geographical barriers for many patients. Since most patients in the U.S. are treated in the community setting, we need more chemotherapy-free, outpatient-ready treatments, like Lunsumio and Polivy." 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 U.S. 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. "Navigating relapsed or refractory large B-cell lymphoma can be challenging, particularly for patients who do not live near a major academic center,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. "The potential new Lunsumio VELO and Polivy combination may address this critical access issue by offering treatment options closer to where a patient lives. It fills a gap in care for people who can't afford to travel far distances or for long periods of time for treatment." Lunsumio is part of Genentech’s industry-leading CD20xCD3 bispecific antibody program. 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. About the SUNMO study The SUNMO study [NCT05171647] is a Phase III, randomized, open-label, multicenter trial evaluating the efficacy and safety of Lunsumio VELO™ (mosunetuzumab-axgb) in combination with intravenously administered Polivy® (polatuzumab vedotin-piiq) versus Rituxan® (rituximab) plus gemcitabine and oxaliplatin (R-GemOx) 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. About Large B-cell Lymphoma (LBCL) 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 specialized academic transplant centers — 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. About Lunsumio VELO™ (mosunetuzumab-axgb) Lunsumio VELO™ is a subcutaneous formulation of mosunetuzumab-axgb, 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 Polivy® (polatuzumab vedotin-piiq) Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL. Lunsumio and Lunsumio VELO U.S. Indication LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments. It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children. The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works. Important Safety Information What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO? LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, and can also be severe or life-threatening. Get medical help right away if you develop any signs or symptoms of CRS at any time, including: fever of 100.4°F (38°C) or higher chills low blood pressure fast or irregular heartbeat tiredness or weakness difficulty breathing headache confusion feeling anxious dizziness or light-headedness nausea vomiting Due to the risk of CRS, you will receive LUNSUMIO or LUNSUMIO VELO on a “step-up dosing schedule.” The step-up dosing schedule is when you receive smaller “step-up” doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the “step-up dosing schedule” You may receive medicines to help reduce your risk of CRS before your dose Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO or LUNSUMIO VELO, if you have severe side effects. What are the possible side effects of LUNSUMIO or LUNSUMIO VELO? LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including: Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO or LUNSUMIO VELO, including: headache numbness and tingling of the arms, legs, hands, or feet dizziness confusion and disorientation difficulty paying attention or understanding things forgetting things or forgetting who or where you are trouble speaking, reading or writing sleepiness or trouble sleeping tremors loss of consciousness seizures muscle problems or muscle weakness loss of balance or trouble walking tiredness Serious infections. LUNSUMIO or LUNSUMIO VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO or LUNSUMIO VELO, including: fever of 100.4°F (38°C) or higher cough chest pain tiredness shortness of breath painful rash sore throat pain during urination feeling weak or generally unwell Hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO or LUNSUMIO VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include: fever enlarged spleen easy bruising low blood cell counts liver problems Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts: low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and neutropenia). Low white blood cells can increase your risk for infection low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems Growth in your tumor or worsening of tumor-related problems (tumor flare). LUNSUMIO or LUNSUMIO VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO or LUNSUMIO VELO: chest pain cough trouble breathing tender or swollen lymph nodes pain or swelling at the site of the tumor Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO or LUNSUMIO VELO if you develop severe side effects. The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage). The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea. The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels. The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels. Before receiving LUNSUMIO or LUNSUMIO VELO, tell your healthcare provider about all of your medical conditions, including if you: have ever had an infusion reaction after receiving LUNSUMIO have an infection or have had an infection in the past which lasted a long time or keeps coming back have or have had Epstein-Barr Virus are pregnant or plan to become pregnant. LUNSUMIO or LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO or LUNSUMIO VELO Females who are able to become pregnant: your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while receiving LUNSUMIO or LUNSUMIO VELO? Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems. These are not all of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO. You may report side effects to the FDA at (800) FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. You may also report side effects to Genentech at (888) 835-2555. Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide and LUNSUMIO VELO full Prescribing Information and Medication Guide and on https://www.Lunsumio.com. Polivy U.S. Indication Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL). Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies. Important Safety Information Possible serious side effects Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects. Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication Side effects seen most often The most common side effects during treatment were Nerve problems in arms and legs Nausea Tiredness or lack of energy Diarrhea Constipation Hair loss Redness and sores of the lining of the mouth, lips, throat, and digestive tract Polivy may lower your red or white blood cell counts and increase uric acid levels. Polivy may not be for everyone. Talk to your doctor if you are Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment. You may report side effects to the FDA at (800) FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. You may also report side effects to Genentech at (888) 835-2555. Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information. About Genentech Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. About Genentech in Hematology-Oncology Genentech has a comprehensive blood cancer portfolio, with approved and investigational treatment options spanning lymphomas, leukemias, and multiple myeloma. For more than 30 years, we’ve developed innovative therapies with novel mechanisms that have transformed the treatment landscape for people living with blood cancers. Our emphasis on developing fixed-duration and outpatient therapies is an important factor in bringing advanced medicines into community settings where most patients are treated. Working in lockstep with the full oncology ecosystem, we are helping to shape the next era of transformative hematology care for all who need it. ###

MISSISSAUGA, ON, June 8, 2026 - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has granted market authorizations for Lunsumio (mosunetuzumab for injection) and Lunsumio SC (mosunetuzumab injection) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grades 1 – 3a) who have received at least two prior systemic therapies. The authorizations include both intravenous (IV) and subcutaneous (SC) formulations, providing healthcare providers and patients with flexible administration options.[1] "The authorization of both IV and SC formulations of Lunsumio reflects Roche’s commitment to providing innovative solutions that address the evolving needs of patients, and the Canadian healthcare systems alike," said Dan Edgcumbe, Vice President Medical & Regulatory Affairs and Country Medical Director, Roche Canada Pharma. Follicular lymphoma is a common, slow-growing form of non-Hodgkin lymphoma (NHL) that often returns after initial treatments.[2,3] It is estimated that in 2025, 12,000 Canadians were diagnosed with NHL.[4] While many patients respond to early lines of therapy, the disease is characterized by cycles of remission and relapse, with each subsequent treatment often becoming less effective.[5] “For Canadians living with follicular lymphoma, the journey is often marked by the uncertainty of relapse. Each time the disease returns, the need for additional treatment options becomes more urgent,” said Antonella Rizza, CEO, Lymphoma Canada. “This authorization is a significant step forward, offering a new sense of hope for patients who continue their treatment journey after previous therapies.” Lunsumio is a T-cell engaging bispecific antibody administered for a fixed duration of 8 or 17 cycles. This regimen provides a predictable treatment schedule for patients with FL, including planned periods off therapy. “In the management of follicular lymphoma, providing patients with options that balance clinical goals with their personal lives is essential. The introduction of new therapies that offer faster, more flexible administration is a meaningful advancement,” said Dr Sarit Assouline, Chief of the Division of Hematology and Senior Investigator at the Jewish General Hospital Montreal. “This flexibility allows us to better tailor the treatment experience to the individual, potentially reducing the time spent in a healthcare setting and supporting the diverse needs of patients across Canada.” The Health Canada authorization is based on results from the pivotal study GO29781, which demonstrated clinically meaningful treatment effect on complete response.[1] Roche Canada is now committed to working with provincial and territorial jurisdictions to ensure that both the IV and SC formulations are accessible to patients across Canada as quickly as possible. About the Health Canada Authorization(1) The approval of Lunsumio and Lunsumio SC was supported by data from the GO29781 study, which evaluated the efficacy and safety of mosunetuzumab. The trial demonstrated that Lunsumio could induce durable remissions in patients who had progressed after multiple previous lines of therapy. The subcutaneous formulation (Lunsumio SC) was specifically designed to provide a more efficient administration route, with a small injection volume (1 mL or less) delivered in minutes, compared to the several hours required for traditional intravenous infusion. About Lunsumio (mosunetuzumab)[1] Lunsumio is a bispecific antibody that targets CD20 on the surface of B-cells and CD3 on the surface of T-cells. Lunsumio attaches to the B cells, including cancerous B cells, and T cells, acting as a bridge between the two cells. This activates the T cells, which can cause them to multiply and kill the B cells. About Follicular Lymphoma[2] Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma. Although it is often responsive to chemotherapy and immunotherapy initially, it is considered incurable, and most patients will experience relapse. For patients who have failed two or more prior therapies, treatment options have historically been limited. About Roche in Hematology Roche 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. About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs around 2,000 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics division in Laval, Québec. For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn. References [1] Lunsumio Product Monograph, April 10, 2026. [2] Canadian Cancer Society. Follicular Lymphoma. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/treatment/treatment-by-type/follicular-lymphoma. Accessed on April 23, 2026. [3] Lymphoma Canada. Follicular Lymphoma Fact Sheet. Available at https://www.lymphoma.ca/wp-content/uploads/2021/08/LymphomaCanada_FactSheet_FL_Digital.pdf. Accessed on April 23, 2026. [4] Canadian Cancer Society. Non-Hodgkin Lymphoma Statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed on April 23, 2026. [4] Canadian Cancer Society. Non-Hodgkin Lymphoma Statistics. Available at https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/statistics. Accessed on April 23, 2026. [5] National Library of Medicine. Clinical outcomes in patients relapsed/refractory after ≥2 prior lines of therapy for follicular lymphoma. Available at https://pmc-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/articles/PMC9869623/. Accessed on April 23, 2026. All trademarks used or mentioned are the property of its respective owner. Media Contact Seraphina Opel Communications Manager Hoffmann-La Roche Limited (Roche Canada) Phone: 1-800-561-1759 Email: mississauga.rochecanada@roche.com You are now leaving the website of Hoffmann-La Roche Ltd. ("Roche Canada"). Links to all external sites are provided as a resource to our visitors. Roche Canada assumes no responsibility for the content of these sites. Roche Canada has no control over these sites and the opinions, claims or comments contained in these sites should not be attributed to Roche Canada, unless otherwise specified.