Glofitamab monotherapy can induce durable remissions in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) after two or more prior lines of therapy; however, its role in the second line setting has not been evaluated. STARGLO, a phase 3, randomised, international trial conducted at 62 centres, investigated the efficacy and safety of glofitamab in combination with gemcitabine-oxaliplatin (Glofit-GemOx) compared with rituximab + gemcitabine-oxaliplatin (R-GemOx) in patients with R/R DLBCL. Transplant-ineligible adults (≥18 years) with confirmed R/R DLBCL after one or more prior therapies were enrolled, were randomly assigned in a 2:1 ratio, and received Glofit-GemOx (intravenous gemcitabine 1,000 mg/m² and oxaliplatin 100 mg/m² plus glofitamab step-up dosing to 30 mg; for a total of eight cycles, plus four additional cycles of glofitamab monotherapy) or R-GemOx (intravenous gemcitabine 1,000 mg/m² and oxaliplatin 100 mg/m² + rituximab 375 mg/m²). The primary endpoint was overall survival (OS). This article presents results from the primary analysis, updated, and landmark analyses to approximately 2 years of follow-up.
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