The US FDA's acceptance of a supplemental Biologics License Application for Lunsumio Velo (mosunetuzumab) in combination with Polivy (polatuzumab vedotin) marks a significant regulatory step for patients with relapsed or refractory large B-cell lymphoma who are ineligible for autologous stem cell transplant — a population with limited chemotherapy-free options and historically poor outcomes. If approved, the combination would represent the first bispecific antibody plus antibody-drug conjugate (ADC) regimen to reach the US market for this indication.
The sBLA, submitted by Roche, seeks approval for the Lunsumio Velo subcutaneous formulation combined with intravenous Polivy for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, after at least one prior line of systemic therapy. The FDA has set a target action date of 9 February 2027, the company said. No priority review designation was reported.
The filing is supported by data from the Phase III SUNMO trial, a randomized, open-label, multicenter study comparing the combination against rituximab plus gemcitabine and oxaliplatin in transplant-ineligible patients. At a median follow-up of 23.2 months, the Lunsumio Velo and Polivy arm demonstrated a statistically significant 59% reduction in the risk of disease progression or death compared with R-GemOx (hazard ratio 0.41; 95% CI: 0.28–0.61; p<0.0001), with a median progression-free survival of 11.5 months versus 3.8 months for R-GemOx. Updated data presented at the 2026 ASCO Annual Meeting and the European Hematology Association Congress indicated continued benefit in PFS with longer follow-up, particularly in second-line patients, with no new safety signals. Cytokine release syndrome occurred in approximately one in four patients on the combination arm, with less than 5% experiencing Grade 2 or 3 events.
Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that simultaneously binds CD20 on malignant B cells and CD3 on T cells, redirecting T-cell cytotoxicity toward the tumor. Polivy is a CD79b-directed ADC that delivers a cytotoxic payload directly into lymphoma cells. Unlike CAR-T therapies and some inpatient-intensive regimens, the fixed-duration subcutaneous Lunsumio Velo regimen may reduce administration burden and facilitate treatment delivery in community practices.