Multinational phase 3 trial of glofitamab plus chemotherapy versus rituximab plus chemotherapy for relapsed or refractory DLBCL

The phase 3 STARGLO trial, at 62 centers in 13 countries, evaluated glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) in transplant-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). Patients with R/R DLBCL after one or more previous therapies were randomized 2:1 to eight cycles of Glofit-GemOx plus four additional cycles of glofitamab monotherapy (n=274) or eight cycles of R-GemOx (n=183). The primary endpoint was overall survival. At the primary analysis after a median follow-up of 11.3 months, overall survival was significantly improved with Glofit-GemOx versus R-GemOx (median NE versus 9.0 months; HR 0,59; p=0.011). At the updated analysis after all patients had completed study therapy (median follow-up 25.5 months), a consistent improvement in overall survival was observed with Glofit-GemOx versus R-GemOx (median 25.5 months versus 12.9 months; HR 0.62; 95% CI 0.43-0.88). All patients in the Glofit-GemOx group and 96% of patients in the R-GemOx group had at least one adverse event. Cytokine release syndrome occurred in 44% of glofitamab-exposed patients and was predominantly low grade. Deaths related to glofitamab or rituximab occurred in 3% of patients in the Glofit-GemOx group and 1% of patients in the R-GemOx group. The authors conclude that Glofit-GemOx had a significant overall survival benefit compared with R-GemOx.