Roche Advances Outpatient-Ready Lunsumio and Polivy Combination for Large B-Cell Lymphoma Review by FDA

Roche Advances Outpatient-Ready Lunsumio and Polivy Combination for Large B-Cell Lymphoma Review by FDA

(IN BRIEF) Roche has announced that the US FDA has accepted its supplemental Biologics License Application for Lunsumio VELO, a subcutaneous formulation of mosunetuzumab, in combination with Polivy for adults with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, after at least one prior line of systemic therapy. The FDA is expected to decide on the application by 9 February 2027. The filing is based on the phase III SUNMO study, where the Lunsumio VELO and Polivy combination reduced the risk of disease progression or death by 59% compared with R-GemOx and delivered median progression-free survival of 11.5 months versus 3.8 months. Roche said the safety profile was consistent with the known profiles of the individual medicines, with low rates of higher-grade cytokine release syndrome. If approved, the regimen could provide a chemotherapy-free, outpatient-ready treatment option for a patient population with high unmet need, particularly in community care settings where many patients face geographic and logistical barriers to advanced therapies.

(PRESS RELEASE) BASEL, 18-Jun-2026 — /EuropaWire/ — Roche has announced that the US Food and Drug Administration has accepted its supplemental Biologics License Application for Lunsumio VELO, a subcutaneous formulation of mosunetuzumab, in combination with Polivy for the treatment of adults with relapsed or refractory large B-cell lymphoma.

The proposed indication covers patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, who have received at least one prior line of systemic therapy. The FDA is expected to make a decision on the application by 9 February 2027.

The filing acceptance is based on results from the phase III SUNMO study, which evaluated Lunsumio VELO in combination with Polivy against MabThera/Rituxan plus gemcitabine and oxaliplatin in patients with relapsed or refractory large B-cell lymphoma who had received at least one prior systemic therapy and were ineligible for autologous stem cell transplant.

At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination demonstrated a 59% reduction in the risk of disease progression or death compared with R-GemOx. Median progression-free survival was 11.5 months for the Lunsumio VELO and Polivy combination, compared with 3.8 months for R-GemOx.

Roche said the safety profile of the combination was consistent with the known profiles of the individual medicines. Cytokine release syndrome occurred in one in four patients receiving Lunsumio VELO plus Polivy, with fewer than 5% of patients experiencing Grade 2 or Grade 3 events.

Updated data from the SUNMO study were recently presented at the American Society of Clinical Oncology Annual Meeting and the European Hematology Association Congress. Roche said the longer follow-up continued to show clinical benefit in progression-free survival, particularly in the second-line setting, with no new safety signals.

Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said relapsed or refractory large B-cell lymphoma is an aggressive disease and remains one of the areas of highest unmet need in lymphoma care. He said that, if approved, the Lunsumio and Polivy combination could offer a chemotherapy-free, outpatient-ready treatment option that may help improve outcomes for patients in this setting.

Tara M. Graff, DO, MS, Director of Clinical Research at Mission Cancer and Blood, said the second-line setting in large B-cell lymphoma is a critical window in which patients need timely access to effective therapies. She noted that some advanced treatment options can involve logistical and geographic barriers, particularly for patients treated outside major academic centres. Since most patients in the US receive care in community settings, she said there is a need for more chemotherapy-free and outpatient-ready options.

Large B-cell lymphoma, composed mainly of diffuse large B-cell lymphoma, is the most common form of non-Hodgkin lymphoma. More than 18,000 people are diagnosed with LBCL each year in the US. Although many patients respond to frontline treatment, up to 40% relapse or develop refractory disease, after which treatment options are limited and survival can be short.

Roche also highlighted the access challenges faced by patients with relapsed or refractory disease. Because this stage of lymphoma can require timely treatment, delays caused by referrals, inpatient coordination or complex treatment logistics can have important clinical consequences.

Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation, said navigating relapsed or refractory large B-cell lymphoma can be particularly difficult for patients who do not live near major academic centres. She said the potential Lunsumio VELO and Polivy combination could help address access challenges by offering treatment options closer to where patients live.

Lunsumio is part of Roche’s CD20xCD3 bispecific antibody programme. It is designed to engage a patient’s own T cells by targeting CD20 on B cells and CD3 on T cells, redirecting the immune response toward malignant B cells. Roche said Lunsumio has the most extensive long-term data for any bispecific antibody in lymphoma.

About the SUNMO study
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.

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.5 DLBCL is a highly aggressive and life-threatening disease.9 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.5,6 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.10,11 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.

About Lunsumio® (mosunetuzumab)
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.

About Polivy® (polatuzumab vedotin)
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.

About Roche in haematology
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. 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 off-the-shelf allogeneic CAR T-cell therapies. 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
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.

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References
[1] Westin J, et al. Mosunetuzumab plus polatuzumab vedotin is superior to R-GemOx in transplant-ineligible patients with R/R LBCL: primary results of the Phase III SUNMO trial. Presented at: ICML; 2025 17-21 June; Lugano, Switzerland, Abstract #LBA3.
[2] Kim W, et al. Mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): Updated efficacy and safety from the phase 3 SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups. Presented at: ASCO Annual Meeting; 2026 May 29-Jun 2; Chicago, IL, USA, Abstract #7007.
[3] Budde E, et al. Mosunetuzumab plus polatuzumab vedotin versus rituximab, gemcitabine and oxaliplatin in large B-cell lymphoma: updated efficacy and safety from the phase 3 SUNMO study including in patient subgroups. Presented at: EHA Congress; 2026 Jun 11-14; Stockholm, Sweden, Abstract #PF968.
[4] Lymphoma Research Foundation. Understanding Diffuse Large B-Cell Lymphoma [Internet; cited June 2026]. Available from: https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/.
[5] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858.
[6] Maurer MJ, et al. Event-free survival at 24 months is a robust end point for disease-related outcome in diffuse large B-cell lymphoma treated with immunochemotherapy. J Clin Oncol. 2014;32:1066-73.
[7] Morimoto S, Jo T, Kitawaki T, et al. Prolonged chimeric antigen receptor-T apheresis to infusion time is associated with inferior outcomes in diffuse large B-cell lymphoma. Br J Haematol. 2025;207(4):1484–1494.
[8] Battiwalla M, et al. Access barriers to anti-CD19+ CART therapy for NHL across a community transplant and cellular therapy network. Blood Advances. 2025;9(2):429-435.
[9] Adiyaman SC, et al. Prognostic Factors in Elderly Patients with Diffuse Large B-Cell Lymphoma and Their Treatment Results. Turk J Haematol. 2019;36(2):81–87.
[10] Patel AR, et al. Access to Chimeric Antigen Receptor T-Cell Therapy in Patients With Diffuse Large B-Cell Lymphoma. JAMA Netw Open. 2025 Oct 22;8(10):e2538602.
[11] Luminari S, et al. Overcoming barriers to referral for CAR T-cell therapy in patients with non-Hodgkin aggressive B-cell lymphomas: A Delphi consensus. Cytotherapy. 2025;27(11):1316-1325.

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