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European Commission approves glofitamab in combination with gemcitabine and oxaliplatin for the treatment of adult patients with R/R DLBCL
On April 14, 2025, the European Commission granted approval to 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 diffuse large B-cell lymphoma (DLBCL) not otherwise specified who are ineligible for autologous stem cell transplant.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 trial evaluating the efficacy and safety of Glofit-GemOx vs rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory DLBCL who have received ≥1 prior line of therapy and who are not candidates for autologous stem cell transplant or who have received ≥2 prior lines of therapy.1 Among the evaluable patients with DLBCL (N = 274)2:
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In the primary analysis, at a median follow-up of 11.3 months, overall survival was longer for Glofit-GemOx vs R-GemOx (hazard ratio, 0.59; 95% confidence interval, 0.40–0.89; p = 0.011).
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In an updated analysis, at a median follow-up of 20.1 months, the median overall survival (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.
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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%).
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