The FDA has accepted a sBLA for subcutaneous mosunetuzumab plus polatuzumab vedotin in R/R LBCL.
The FDA has accepted a supplemental biologics license application (sBLA) for the subcutaneous formulation of mosunetuzumab (Lunsumio Velo) in combination with polatuzumab vedotin (Polivy) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least 1 prior line of systemic therapy.1 The FDA is expected to make a decision on approval by February 9, 2027.
The sBLA is supported by data from the phase 3 SUNMO trial (NCT05171647) trial. At a median follow-up of 28.3 months, updated findings from SUNMO presented during the
“Relapsed or refractory LBCL is an aggressive disease, thereby representing one of the highest unmet needs in lymphoma care,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in a news release.1 “If approved, this [mosunetuzumab/polatuzumab vedotin] combination could provide an important chemotherapy-free, outpatient-ready option to help improve outcomes in this setting.”
SUNMO enrolled patients with relapsed/refractory LBCL who had received at least 1 prior line of therapy and were ineligible for autologous stem cell transplantation.2 The study included patients with DLBCL not otherwise specified, transformed follicular lymphoma, high-grade B-cell lymphoma, and grade 3 follicular lymphoma. Patients were stratified by number of prior lines of therapy (1 vs 2 or more) and relapsed vs refractory disease.
Eligible patients were randomly assigned 2:1 to receive subcutaneous mosunetuzumab for 8 cycles plus intravenous (IV) polatuzumab vedotin for 6 cycles via 21-day treatment cycles or to the chemotherapy arm. In the chemotherapy arm, patients received 8 cycles of IV rituximab, gemcitabine, and oxaliplatin every 14 to 21 days.
The primary end points were PFS and overall response rate (ORR), both by IRC assessment. Overall survival (OS) was a key secondary end point; safety was also assessed as a secondary end point.
The ORR in the investigational arm was 70.3% (95% CI, 61.9%-77.8%) vs 40.0% (95% CI, 28.5%-52.4%) in the chemotherapy arm. The respective complete response (CR) rates were 51.4% (95% CI, 42.8%-60.0%) and 24.3% (95% CI, 14.8%-36.0%). The median duration of response (DOR) was 18.8 months (95% CI,11.5-not evaluable [NE]) vs 6.0 months (95% CI, 3.7-23.9), respectively. The respective 2-year DOR rates were 47.9% (95% CI, 37.0%-58.8%) and 15.4% (95% CI, 0.0%-39.8%). The median durations of CR were not reached and 18.3 months (95% CI, 3.9-NE), respectively; the respective 2-year duration of CR rates were 62.5% (95% CI, 50.1%-74.9%) and 22.0% (95% CI, 0.0%-56.2%).
The safety profile of mosunetuzumab plus polatuzumab vedotin was consistent with the known profiles of the individual agents. In the investigational arm (n = 135), any-grade cytokine release syndrome (CRS) was reported in 25.9% of patients, consisting of grade 1 (21.5%), 2 (3.7%), and 3 (0.7%) CRS events. Serious CRS occurred in 5.2% of patients. The median time to onset of first instance of CRS was 3 days (range, 1-6), and the median duration of CRS was also 3 days (range, 1-11).
"Navigating relapsed or refractory LBCL can be challenging, particularly for patients who do not live near a major academic center,” Meghan Gutierrez, CEO of the Lymphoma Research Foundation, said in the news release.1 "The potential new [mosunetuzumab and polatuzumab vedotin] 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."
