CHMP recommends EMA approval of glofitamab in combination with gemcitabine and oxaliplatin for the treatment of adult patients with R/R DLBCL

On February 28, 2025, it was announced that the Committee for Medicinal Products for Human Use (CHMP) recommended the European Medicines Agency’s (EMA) approval of glofitamab (Glofit), a CD20×CD3 T-cell-engaging bispecific antibody, in combination with gemcitabine and oxaliplatin (GemOx), for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, and who are ineligible for autologous stem cell transplant (ASCT).¹ This announcement is based on key results from the pivotal phase III STARGLO trial NCT04408638.¹

STARGLO trial

STARGLO is a phase III, multicenter, open-label, randomized study evaluating the efficacy and safety of Glofit-GemOx vs rituximab plus GemOx (R-GemOx) in patients with R/R DLBCL who have received ≥1 prior line of therapy and who are not candidates for ASCT or who have received ≥2 prior lines of therapy.¹ Among the evaluable patients with DLBCL (N = 274)²: 

• At the primary analysis, with a median follow-up of 11.3 months, overall survival (OS) was longer for Glofit-GemOx vs R-GemOx (hazard ratio [HR], 0.59; 95% CI, 0.40–0.89; p = 0.011).²
  • Glofit-GemOx reduced the risk of death by 41% compared to R-GemOx.¹
• At an updated analysis, with a median follow-up of 20.1 months, the median OS (25.5 months vs 12.9 months; p = 0.0064) and median progression-free survival (13.8 months vs 3.6 months; p < 0.0001) were higher for Glofit-GemOx vs R-GemOx.² 
• Safety of Glofit-GemOx was consistent with the known safety profiles of the individual agents. Cytokine release syndrome occurred in 44% of patients in the Glofit-GemOx group, and was mostly low grade (Grade 1, 31%; Grade 2, 10%; and Grade 3, 2%).²

Glofit-GemOx combination is designed to be an off-the-shelf, fixed-duration treatment, which would provide a readily available option for patients with R/R DLBCL. If approved, the combination would become the first bispecific antibody regimen available for patients with R/R DLBCL.¹