Posted: Friday, December 23, 2022
On December 22, Genentech announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to mosunetuzumab-axgb (Lunsumio) for the treatment of adults with relapsed or refractory follicular lymphoma or after two or more lines of systemic therapy for follicular lymphoma. This agent, which is the first CD20 x CD3 T-cell–engaging bispecific antibody approved by the FDA to treat this type of non-Hodgkin lymphoma, represents a new class of fixed-duration cancer immunotherapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
This approval is based on the results from the phase II GO29781 study of mosunetuzumab in individuals with heavily pretreated follicular lymphoma, including those who were at high risk of disease progression or whose disease was refractory to prior therapies. In this trial, 80% of patients who received at least two prior therapies achieved durable response rates with the bispecific antibody, with 60% experiencing complete remission. An updated analysis from this trial was presented recently at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition.
The most common adverse event reported with mosunetuzumab was cytokine-release syndrome, with a median duration of 3 days. Other common adverse events (≥ 20%) included fatigue, rash, pyrexia, and headache.