STARGLO: Long-term clinical benefits of Glofit-GemOx over R-GemOx in DLBCL

After 2 years of follow-up, glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) was superior to rituximab (R)-GemOx regarding therapy response and survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). These findings support the use of Glofit-GemOx in autologous stem-cell transplant (ASCT)-ineligible patients with DLBCL who had received at least 1 prior therapy.

The phase 3 STARGLO trial randomised 274 ASCT-ineligible patients with relapsed or refractory DLBCL 2:1 to Glofit-GemOx or R-GemOx [1,2]. Participants in the experimental arm received 8 21-day cycles of Glofit-GemOx and 3 cycles of glofitamab monotherapy. The primary analysis demonstrated that the glofitamab-containing regimen outperformed the rituximab-containing regimen for overall survival (OS), progression-free survival (PFS), and other clinical outcomes [1]. In the current analysis, Dr Gareth Gregory (Monash University, Australia) shared the findings after 2 years of follow-up [2].

The 24-month OS rates were 54.4% for participants on glofitamab and 33.6% for participants on rituximab (HR 0.60; 95% CI 0.42–0.85; P=0.003), showing a clinically meaningful OS benefit for Glofit-GemOx over R-GemOx. In addition, the median PFS was 13.8 months in the Glofit-GemOx arm and 3.6 months in the R-GemOx arm (HR 0.41; 95% CI 0.29–0.58; P<0.001). “Over 80% of the participants in the glofitamab arm with a complete response at end-of-treatment [n=82] was alive and did not have disease progression 12 months after the therapy was concluded,” said Dr Gregory. Next to this, he mentioned that immune recovery was observed at 18–24 months after fixed-duration treatment with Glofit-GemOx. “Finally, the safety profiles of the treatment regimens remained manageable and consistent with the known safety profiles of the respective study drugs,” stated Dr Gregory.

“These updated results support the use of Glofit-GemOx as a fixed-duration, off-the-shelf therapy for ASCT-ineligible patients with relapsed or refractory DLBCL,” concluded Dr Gregory.

1. Abramson JS, et al. Lancet. 2024;404:1940-1954.
2. Gregory GP, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year follow-up of STARGLO. PS1909, EHA2025 Congress, 12–15 June, Milan, Italy.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 16 June 20251 July 2025