Glofitamab combination sustains long-term benefit in relapsed/refractory DLBCL

The phase 3 STARGLO 2-year follow-up data reinforced the durable efficacy and manageable safety profile of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx) for participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplantation.

The updated data from STARGLO (NCT04408638), presented by Prof. Jeremy Abramson (Harvard Medical School, MA, USA), builds on the recently published initial analysis available in The Lancet [1,2]. Glofitamab is a bispecific CD20:CD3 antibody that redirects CD3⁺ T cells to target malignant CD20⁺ B cells. STARGLO compared Glofit-GemOx with the standard-of-care rituximab-based GemOx (R-GemOX) regimen in participants (n=274) who had received at least 1 prior line of therapy. In this 2:1 randomised trial, participants in the experimental arm received 8 cycles of Glofit-GemOx followed by 4 cycles of glofitamab monotherapy (n=183) or standard therapy (R-GemOx; n=91). Over 60% of the included DLBCL study population were refractory to their last line of treatment, and more than half were classified as primary refractory. These represent a particularly high-risk population with limited treatment options.

At a median follow-up of just under 25 months, Glofit-GemOx continued to demonstrate a significant overall survival (OS) benefit, with the median OS not yet reached in the experimental arm, compared with 13.5 months in the R-GemOx arm (HR 0.60, 95% CI 0.42–0.85). Progression-free survival, as assessed by an independent review committee, was also significantly longer (13.8 vs 3.6 months, Glofit-GemOx vs R-GemOx; HR 0.41; 95% CI 0.29–0.58). The complete response rate with Glofit-GemOx was more than twice that of the comparator arm (58.5% vs 25.3%).

For participants who achieved complete remission at the end of treatment, outcomes were particularly encouraging. The median duration of response had not yet been reached after more than 18 months of follow-up, and survival rates remained high: 89.3% were alive 1 year after completing treatment, and 82.4% remained progression-free.

The safety profile of Glofit-GemOx remained consistent with expectations. Cytokine release syndrome was the most frequently reported adverse event, occurring in nearly half of the participants, though most cases were grade 1 or 2. Mild neurotoxicity consistent with immune effector cell-associated neurotoxicity syndrome was observed in 4 participants.

1. Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. Abstract #7015, ASCO Annual Meeting 2025, 30 May–3 June, Chicago, IL, USA.
2. Abramson JS, et al. 2024;404(10466):1940–1954.

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Posted on 30 July 2025