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ASH 2021 | Pivotal findings from a Phase I/II trial of mosunetuzumab monotherapy for R/R follicular lymphoma

Mosunetuzumab is a novel CD20-CD3 T-cell engaging bispecific antibody under investigation for the treatment of CD20-postitive B-cell non-Hodgkin lymphomas. One such investigation is assessing the use of mosunetuzumab monotherapy for patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies. Relapses are common in follicular lymphoma and with currently available agents, progression-free intervals shorten with each successive treatment. The ongoing Phase I/II study (NCT02500407) began with a standard dose-escalation phase, which showed mosunetuzumab to be highly active and well tolerated in this population. Elizabeth Budde, MD, PhD, City of Hope, Duarte, CA, shares the pivotal dose-escalation results from the second phase of the trial. In total, 90 patients were enrolled and treated with intravenous mosunetuzumab, using cycle 1 step-up dosing to mitigate cytokine release syndrome (CRS). Best objective response rate was 78.9%, with almost 58% reaching complete response. At the time of data cut off, median duration of response was not reached. CRS events were mostly low grade and easily managed. Common high grade adverse events occurred in 66.7% of patients and included neutropenia, hypophosphatemia, hyperglycemia, and anemia. These data demonstrate that mosunetuzumab use elicits deep and durable response, with an acceptable safety profile. Mosunetuzumab is currently under FDA review as a monotherapy for R/R follicular lymphoma and is under continued investigation in a Phase III trial in combination with lenalidomide compared to rituximab plus lenalidomide. This press briefing was recorded at the American Society of Hematology (ASH) 2021 Annual Meeting and Exposition in Atlanta, GA.