Posted: Monday, January 9, 2023
On January 6, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s biologics license application and granted Priority Review for glofitamab in the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The FDA is expected to make a decision on this application for this fixed-duration, off-the-shelf CD20 x CD3 T-cell–engaging bispecific antibody by July 2023.
The application is based on results from the phase I/II NP30179 trial (ClinicalTrials.gov identifier NCT03075696). This multicenter, open-label, dose-escalation, dose-expansion study is evaluating the safety, efficacy, and pharmacokinetics of glofitamab in people with relapsed or refractory DLBCL. In this study, 85.1% of patients had disease that was refractory to their most recent therapy, and about one-third (33.1%) had received prior chimeric antigen receptor (CAR) T-cell therapy.
Results from this trial showed that 40.0% of patients (62 of 155) achieved a complete response, and 51.6% (80 of 155) achieved an objective response. The median follow-up time was 13.4 months. Among those who achieved a complete response, 73.1% continued to experience a response at 12 months, and the median duration of complete response was not reached. The median duration of response was 18.4 months.
The most common adverse event with glofitamab was cytokine-release syndrome, which was generally low grade (48.1% of patients had grade 1 and 12.3% had grade 2). Most cytokine-release syndrome events were associated with initial administration of glofitamab (during cycle 1). The incidence of grade 3 or higher cytokine-release syndrome was 3.9%, with no grade 5 events. One patient (of 155 patients) discontinued glofitamab because of cytokine-release syndrome.
Additional studies are ongoing to investigate glofitamab as a monotherapy and in combination with other agents in the treatment of patients with B-cell non-Hodgkin lymphomas, including diffuse LBCL, mantle cell lymphoma, and other hematologic malignancies.