FDA Grants Priority Review to Bispecific Antibody Glofitamab for Relapsed or Refractory LBCL

The U.S. Food and Drug Administration (FDA) has granted priority review for glofitamab, an investigational CD20×CD3 T-cell-engaging bispecific antibody, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20×CD3 T-cell-engaging bispecific antibody available to treat patients with aggressive lymphoma who have previously received multiple courses of treatment.

The Biologics License Application (BLA) submitted on behalf of glofitamab is based on positive data from the pivotal phase I/II NP30179 multicenter, open-label, dose-escalation and expansion study, which included patients who had previously received multiple courses of therapy, with 85.1% of patients refractory to their most recent therapy and approximately one-third (33.1%) having received prior chimeric antigen receptor T-cell therapy.

Results showed that 40% of patients (n=62/155) achieved a complete response (CR), and 51.6% (n=80/155) achieved an objective response (combination of CR and partial response) after glofitamab administration. The median follow-up time from glofitamab administration was 13.4 months. Among those who achieved a CR, 73.1% continued to experience a response at 12 months, while the median duration of CR was not reached. The median duration of response was 18.4 months after glofitamab administration.

The most common adverse event was cytokine release syndrome (CRS), which was generally low grade (48.1% of patients had grade 1 and 12.3% had grade 2). Most CRS events were associated with initial administration of glofitamab (in cycle 1). The incidence of grade 3 or higher CRS was 3.9%, with no grade 5 events. Only one patient (n=1/155) discontinued glofitamab due to CRS.

The FDA will review the glofitamab BLA under the granted Fast Track Designation. Data from the phase I/II NP30179 study of glofitamab were submitted for review to the European Medicines Agency.

Source: Genentech, January 2023