Roche has announced that the US FDA has accepted its supplemental Biologics License Application (sBLA) for Lunsumio VELO-Polivy combo for adults with relapsed or refractory large B-cell lymphoma.
The FDA is expected to decide on approval by 9 February 2027, on VELO (mosunetuzumab) in a subcutaneous formulation and Polivy (polatuzumab vedotin).
The filing is backed by Phase III SUNMO study results showing a clear clinical advantage over standard care.
At a median follow-up of 23.2 months, the combination reduced the risk of disease progression or death by 59% compared with MabThera/Rituxan (rituximab) plus gemcitabine and oxaliplatin (R-GemOx), with a hazard ratio of 0.41. Median progression-free survival reached 11.5 months versus 3.8 months for R-GemOx.
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines.
“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, 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.”
Clinical experts emphasized the urgency of earlier, easier-to-access treatment options.
“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, 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.”
LBCL, predominantly diffuse large B-cell lymphoma, is the most common non-Hodgkin lymphoma in the US, with more than 18,000 new cases annually. While frontline therapy is often effective, up to 40% of patients relapse or become refractory, and outcomes worsen significantly at that stage due to limited options and rapid disease progression.
“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, part of Roche’s CD20xCD3 bispecific antibody programme, is designed to enable outpatient use and flexible administration, including intravenous and subcutaneous options.
Both Lunsumio IV and Lunsumio VELO are already approved for third-line or later follicular lymphoma. The programme continues to expand, with ongoing Phase III studies CELESTIMO and MorningLyte evaluating combinations in earlier lines of follicular lymphoma treatment.
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