Résumé
Glofitamab combined with GemOx has demonstrated survival benefits in patients with R/R DLBCL ineligible for autologous stem cell transplant (ASCT) in the STARGLO trial (NCT04408638).
Present updated efficacy and safety data from STARGLO for Glofit-GemOx vs rituximab combined with GemOx (R-GemOx) in patients with R/R DLBCL.
Patients were randomized 2:1 to Glofit-GemOx (8 cycles plus 4 cycles glofitamab monotherapy) or R-GemOx (8 cycles), stratified by number of prior therapies (1 vs ≥2) and refractoriness to last therapy. After obinutuzumab pretreatment, glofitamab was given in cycle 1 as weekly step-up doses (2.5/10 mg) then as a 30-mg target dose from cycle 2 day 1 (21-day cycles). Primary endpoint was overall survival (OS). Secondary endpoints were independent review committee–assessed progression-free survival (PFS) and complete remission (CR) rate. A landmark analysis of patients in CR at end of treatment (EOT) was explored.
Of 274 patients (Glofit-GemOx, n = 183; RGemOx, n = 91), 62.8% had 1 prior therapy, 37.2% had ≥2 prior therapies, 55.8% were primary refractory, and 60.6% were refractory to last therapy. Baseline characteristics were balanced across arms. With 24.7 months’ median follow-up (data cut-off: June 17, 2024), Glofit-GemOx continued to demonstrate superior median OS (not evaluable [NE] vs 13.5 months; HR, 0.60; 95% CI, 0.42–0.85), median PFS (13.8 vs 3.6 months; HR, 0.41; 95% CI, 0.29–0.58), and CR rate (58.5% vs 25.3%) vs R-GemOx, respectively. For Glofit-GemOx–treated patients in CR (n = 107), median duration of CR was not reached (95% CI, 27.2–NE; median CR follow-up, 18.2 months). In patients with a CR at EOT, the OS and PFS rates 1 year after EOT were 89.3% and 82.4%, respectively. The Glofit-GemOx safety profile was unchanged. Cytokine release syndrome was the most common adverse event in glofitamab-exposed patients (predominantly grade 1/2).
At 2-year follow-up, Glofit-GemOx sustained its clinically meaningful benefit in OS and PFS vs R-GemOx in ASCT-ineligible patients with R/R DLBCL, with most patients in CR at EOT still in remission. The safety profile was consistent with known risks of each drug. c 2025 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2025 ASCO Annual Meeting. All rights reserved.