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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
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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
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Data will be submitted to health authorities and presented at an upcoming medical meeting
South San Francisco, CA -- September 16, 2026 --Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the Phase III CELESTIMO study evaluating Lunsumio® (mosunetuzumab-axgb) in combination with lenalidomide versus Rituxan® (rituximab) plus lenalidomide in people with relapsed or refractory 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. Overall survival data were immature at the time of interim analysis. The safety profile of 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, M.D., Ph.D., 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 authorization 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 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 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.
With the longest follow-up data of any bispecific antibody in lymphoma and a broad clinical development program 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 recently accepted the supplemental Biologics License Application for Lunsumio in combination with Polivy® (polatuzumab vedotin-piiq) 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-axgb) in combination with lenalidomide vs. 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 authorization 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 (FL)
Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterized by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, more than 15,000 new cases of FL will be diagnosed in 2026, and more than 110,000 people are diagnosed with FL each year worldwide.
About Lunsumio® (mosunetuzumab-axgb)
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 target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse 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.
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.
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.