FDA accepts supplemental Biologics License Application for Roche’s Lunsumio and Polivy combination in relapsed or refractory large B-cell lymphoma

Roche has confirmed that the US Food and Drug Administration has accepted its supplemental Biologics License Application for Lunsumio VELO (mosunetuzumab), in subcutaneous form, combined with Polivy (polatuzumab vedotin), for the treatment of adults with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, following at least one prior systemic therapy line. A regulatory decision is anticipated by 9 February 2027.

The basis for the filing acceptance lies in results from the Phase III SUNMO study. At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination cut the risk of disease progression or death by 59% relative to rituximab, gemcitabine, and oxaliplatin, and delivered a median progression-free survival of 11.5 months, roughly three times the 3.8 months recorded in the comparator arm. The safety profile of the combination remained in line with what is already known about each medicine on its own, and the incidence of cytokine release syndrome was low, affecting one in four patients, with fewer than 5% experiencing grade 2 or 3 events.

More recent data presented at both the American Society of Clinical Oncology Annual Meeting and the European Hematology Association Congress showed that with extended follow-up, the combination continued to deliver clinical benefit in progression-free survival, most notably in the second-line setting, with no new safety concerns arising.

“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, MD, PhD, Roche’s 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, DO, MS, 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 US are treated in the community setting, we need more chemotherapy-free, outpatient-ready treatments, like Lunsumio and Polivy.”

Large B-cell lymphoma, with diffuse large B-cell lymphoma making up the bulk of cases, is the most frequently diagnosed form of non-Hodgkin lymphoma, with over 18,000 new cases emerging each year across the US. Although it tends to respond well to initial treatment, up to 40% of patients will eventually see their disease relapse or prove refractory, at which point salvage options become limited and survival prospects narrow considerably. Given the time-sensitive nature of this disease stage, delays rooted in referral requirements, inpatient logistics, or treatment complexity can carry real clinical consequences.

“Navigating relapsed or refractory large B-cell lymphoma can be challenging, particularly for patients who do not live near a major academic centre,” 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 sits within Roche’s CD20xCD3 bispecific antibody programme and has been developed with a focus on patient convenience, supporting outpatient treatment and offering flexibility between intravenous and subcutaneous administration. Both Lunsumio IV and Lunsumio VELO carry approval for people with third-line or later follicular lymphoma, and Lunsumio holds the broadest long-term dataset of any bispecific antibody in lymphoma. Further development work continues through the Phase III CELESTIMO and MorningLyte studies, examining the therapy in combination with other treatments in the second-line or later and frontline follicular lymphoma settings respectively.

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Related Topics and Keywords

lunsumio, lymphoma, refractory large b cell lymphoma, Roche, Roche’s Lunsumio