Roche announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, in combination with Polivy (polatuzumab vedotin) for the treatment of adult patients with relapsed or refractory Large B-Cell Lymphoma (LBCL), including Diffuse Large B-Cell Lymphoma (DLBCL), after at least 1 prior line of systemic therapy.

The FDA is expected to make a decision on approval by February 9, 2027.

The sBLA acceptance is based on results from the phase 3 SUNMO study. At a median follow-up of 23.2 months, the Lunsumio VELO and Polivy combination demonstrated a 59 percent reduction in risk of disease progression or death (Progression-Free Survival [PFS]) compared to MabThera/Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx) (Hazard Ratio [HR] 0.41, 95 percent Confidence Interval [CI]: 0.28-0.61; p<0.0001) and a 3-times longer median PFS at 11.5 months (95 percent CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95 percent CI: 2.9-4.1). The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines. The incidence of Cytokine Release Syndrome (CRS) events in the Lunsumio VELO plus Polivy arm was low, occurring in 1 in 4 patients, with less than 5 percent of patients experiencing Grade 2 or 3 CRS events.

Levi Garraway, MD, PhD, Chief Medical Officer (CMO) and Head—Global Product Development, said, “Relapsed or refractory Large B-Cell Lymphoma is an aggressive disease thereby representing one of the highest unmet needs in lymphoma care. If approved, this Lunsumio/Polivy combination could provide an important chemotherapy-free, outpatient-ready option to help improve outcomes in this setting.”

LBCL, composed predominantly of DLBCL, is the most common type of non-Hodgkin lymphoma with more than 18,000 new diagnoses each year in the US. While it is generally responsive to treatment in the frontline, as many as 40 percent of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short. Because this stage of disease is time-sensitive, delays caused by referral requirements, inpatient coordination, or complex treatment logistics can have meaningful clinical consequences.

Meghan Gutierrez, Chief Executive Officer (CEO), Lymphoma Research Foundation, said, "Navigating relapsed or refractory Large B-Cell Lymphoma can be challenging, particularly for patients who do not live near a major academic centre. 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 is part of Roche’s 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 (IV) and subcutaneous administration routes.