FDA accepts supplemental biologics license application for glofitamab-gxbm for R/R DLBCL

Glofitamab, a CD20 × CD3 T-cell engaging bispecific antibody, previously received accelerated approval from the U.S. Food and Drug Administration (FDA) and conditional marketing authorization approval from the European Commission (EC) for the treatment of patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.¹

On December 5, 2024, it was announced that the FDA accepted a supplementary biologics application for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx), for the treatment of patients with R/R DLBCL who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant. This application is based on positive results from the phase III STARGLO trial (NCT04408638).²

Key data from the STARGLO trial²

The STARGLO trial is a multicenter, open-label, randomized, phase III study evaluating the efficacy and safety of Glofit-GemOx vs rituximab plus gemcitabine and oxaliplatin (R-GemOx) in patients with R/R DLBCL who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Among the evaluable patients with R/R DLBCL:

• With a median follow-up of 11.3 months, OS was significantly longer in Glofit-GemOx vs R-GemOx, with a 41% reduction in the risk of death (hazard ratio [HR], 0.59; 95% CI, 0.40–0.89; p = 0.011).
• Median OS was not reached with Glofit-GemOx vs 9 months for R-GemOx.
• Safety of Glofit-GemOx was consistent with the known safety profiles of the individual agents. Adverse event (AE) rates were higher with Glofit-GemOx vs R-GemOx.
  • Cytokine release syndrome primarily occurred in Cycle 1, and was generally low grade (any grade, 44.2%; Grade 1, 31.4%; Grade 2, 10.5%; Grade 3, 2.3%).