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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
References
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