Rituximab

Roche announced Thursday that a confirmatory study of Lunsumio (mosunetuzumab) in people with relapsed or refractory follicular lymphoma (FL) who have received at least one prior line of treatment met its primary endpoint of progression-free survival, setting up full approval of the CD20xCD3 T-cell engaging bispecific antibody and potentially moving it into earlier lines of treatment.Lunsumio gained EU and US approval in 2022 for adults with relapsed or refractory FL who have received at least two prior systemic therapies. The decisions were based on objective response rate data from the Phase II GO29781 study.At the time, the Phase III CELESTIMO trial was already under way. In the study, people with relapsed or refractory FL who have received at least one line of prior systemic therapy were randomised to receive Lunsumio or Roche's anti-CD20 antibody MabThera/Rituxan (rituximab), both in combination with lenalidomide.Roche said Thursday that the trial achieved its main efficacy goal at the interim analysis, with the Lunsumio arm demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression. The company added that overall survival (OS) data are still immature at this time."The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey," said Chief Medical Officer Levi Garraway. Roche noted that the findings will be submitted to health authorities in an effort to convert the original EU and US decisions to full approvals, while also seeking an indication in second-line or later FL. The data will also be presented at an upcoming medical meeting.The FDA recently accepted a filing seeking approval of Lunsumio in combination with Roche's anti-CD79b antibody-drug conjugate Polivy (polatuzumab vedotin) for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least one prior line of systemic therapy. The agency is expected to make a decision on approval by Feb. 9 next year.Meanwhile, Biogen exercised an option to participate in the development of mosunetuzumab in 2022. Under the agreed terms, Biogen will share in the operating profits and losses of the drug in the US in the low- to mid-30% range, and is eligible to receive low-single-digit royalties on sales outside the country.

Phase III CELESTIMO study met its primary endpoint at the interim analysis demonstrating a statistically significant and clinically meaningful reduction in the risk of disease progression in people with follicular lymphoma who have received at least one prior line of treatment Data reinforce the potential of this Lunsumio-based regimen to improve clinical outcomes, while offering a tolerable safety profile, simple dosing schedule and outpatient administration Data will be submitted to health authorities and presented at an upcoming medical meeting Basel, 17 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the phase III CELESTIMO study evaluating Lunsumio® (mosunetuzumab) in combination with lenalidomide versus MabThera®/Rituxan® (rituximab) plus lenalidomide in people with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one prior line of treatment met its primary endpoint. Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Overall survival (OS) data were immature at the time of interim analysis. The safety pro the Lunsumio and lenalidomide combination was consistent with the known profiles of the individual study medicines, with no new safety signals identified. Data from the study will be submitted to health authorities and presented at an upcoming medical meeting. “People living with relapsed or refractory follicular lymphoma need treatment options that provide meaningful clinical benefit and minimal disruptions to everyday care,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The CELESTIMO results indicate that a two-drug outpatient Lunsumio regimen may offer these patients an effective new option earlier in their treatment journey." CELESTIMO is a confirmatory study required to convert the accelerated approval/conditional marketing authorisation of Lunsumio monotherapy for third-line or later (3L+) FL to full approval, as well as to secure an indication in second-line or later (2L+) FL. 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 and subcutaneous administration routes. Lunsumio is already approved for people with 3L+ FL in 60 countries worldwide and has been used to treat over 3,800 patients. 1 With the longest follow-up data of any bispecific antibody in lymphoma and a broad clinical development programme spanning multiple disease settings, including both FL and diffuse large B-cell lymphoma (DLBCL), Lunsumio is helping redefine care across B-cell malignancies. The U.S. Food and Drug Administration (FDA) recently accepted the supplemental Biologics License Application (sBLA) for Lunsumio in combination with Polivy® (polatuzumab vedotin) for 2L+ DLBCL based on the SUNMO study, and results from CELESTIMO support continued expansion of Lunsumio and lenalidomide into earlier FL treatment, with the phase III MorningLyte study ongoing in first-line FL. About the CELESTIMO study CELESTIMO [ NCT04712097 ] is a phase III trial evaluating the efficacy and safety of Lunsumio® (mosunetuzumab) in combination with lenalidomide vs. MabThera®/Rituxan® (rituximab) plus lenalidomide in people with relapsed or refractory follicular lymphoma (FL) who have received at least one line of prior systemic therapy. It is a confirmatory study required to convert the accelerated approval/conditional marketing authorisation of Lunsumio monotherapy for third-line or later FL to full approval, as well as to secure an indication in second-line or later FL. About follicular lymphoma Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases. 2 It typically responds well to treatment but is often characterised by periods of remission and relapse. 3 The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. 4 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide. 5 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 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. 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 . All trademarks used or mentioned in this release are protected by law. References [1] Roche data on file. [2] Lymphoma Research Foundation. About Follicular Lymphoma. [Internet; cited September 2026]. Available from: [3] Lymphoma Action. Follicular Lymphoma. [Internet; cited September 2026]. Available from: [4] Skarbnik AZ et al. Treatment selection for patients with relapsed or refractory follicular lymphoma. Front Oncol. 2023;13:1120358. [5] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited September 2026]. Available from: . 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