STARGLO trial of glofitamab: primary endpoint met in R/R DLBCL

On April 15, 2024, it was announced that the phase III STARGLO trial (NCT04408638) assessing glofitamab, a CD20 × CD3 T-cell engaging bispecific antibody, plus gemcitabine and oxaliplatin vs rituximab plus gemcitabine and oxaliplatin met its primary endpoint of overall survival. Glofitamab in combination with gemcitabine and oxaliplatin demonstrated a statistically significant improvement in overall survival for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy and were not candidates for autologous stem cell transplant. The safety profile of the combination was consistent with the known safety profiles of the individual treatments.

Glofitamab previously received accelerated approval from the U.S. Food and Drug Administration (FDA) and conditional marketing authorization from the European Commission (EC) for the treatment of patients with R/R DLBCL after two or more lines of systemic therapy.

These encouraging data show that glofitamab in combination with gemcitabine and oxaliplatin has the potential to improve survival outcomes in earlier lines of treatment for patients with R/R DLBCL, who currently have limited options.