Glofitamab plus gemcitabine and oxaliplatin for relapsed/refractory DLBCL: 3-year follow-up of STARGLO

In the phase 3 STARGLO trial, glofitamab plus gemcitabine-oxaliplatin (Glofit-GemOx) demonstrated superior overall survival (OS) vs rituximab plus GemOx (R-GemOx), in patients with autologous stem cell transplant (ASCT)-ineligible relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). We present efficacy and safety from STARGLO, with 3 years of follow-up, including in clinically relevant subgroups. After a median OS follow-up of 35.1 months (data cutoff: 1 May 2025), Glofit-GemOx continued to demonstrate favorable outcomes vs R-GemOx, respectively: median OS, 25.5 vs 12.5 months (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.4-0.8); median progression-free survival, 14.4 vs 3.3 months (HR, 0.41; 95% CI, 0.3-0.6); complete response rate, 58.5% vs 25.3%. Glofit-GemOx was particularly efficacious in the second-line (2L) vs third-line or later setting (3-year OS rate, 54.6% [95% CI, 45.2-64.0] vs 33.2% [95% CI, 21.2-45.3]). In the 2L setting, among patients with primary refractory disease or early treatment failure, the 36-month OS rate was 46.1% (95% CI, 35.2-56.9) with Glofit-GemOx vs 16.5% (95% CI, 3.4-29.6) with R-GemOx. Glofit-GemOx was favorable over R-GemOx regardless of patient age, with consistent efficacy observed across age categories, including in older patients (aged ≥75 years). No new safety signals were identified. With extended follow-up, fixed-duration Glofit-GemOx continues to demonstrate superior survival vs R-GemOx in ASCT-ineligible patients with R/R DLBCL, with favorable outcomes pronounced in the 2L setting, and consistent across subgroups including older patients and those with early relapsing disease. These data support Glofit-GemOx as an effective off-the-shelf treatment with curative potential in R/R DLBCL. This trial was registered at www.clinicaltrials.gov as NCT04408638.