What do the 3-year follow-up results from the STARGLO trial tell us about Glofit-GemOx in R/R DLBCL?

The Lymphoma Hub was pleased to speak with Christopher P. Fox, University of Nottingham, UK. We asked, What do the 3-year follow-up results from the STARGLO trial tell us about Glofit + GemOx in R/R DLBCL? 

In this interview, Fox discusses the 3-year follow-up results from the global, randomized, phase III STARGLO trial (NCT04408638) of glofitamab (Glofit) + gemcitabine + oxaliplatin (GemOx) (n = 183) vs rituximab (R)-GemOx (n = 91) in transplant-ineligible patients with R/R diffuse large B-cell lymphoma (DLBCL), recently published in Blood Advances. He also explores outcomes across clinically relevant subgroups. 

Key points

• Primary results from the STARGLO trial suggested an overall survival (OS) benefit with Glofit-GemOx in transplant-ineligible patients with R/R DLBCL.¹ 
• Updated results, with a median OS follow-up of 35.1 months, show that Glofit-GemOx continued to demonstrate superior OS vs R-GemOx, with a median OS of 25.5 months vs 12.5 months (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.4–0.8).²
• Glofit-GemOx also improved complete response (CR) rates (58.5% vs 25.3%) and 30-month progression-free survival rates (38.1% vs 15.2%) vs R-GemOx.²  
• Among patients treated in the second-line setting, the CR rate was 63.5% with Glofit-GemOx vs 28.1% with R-GemOx, and median OS was not reached with Glofit-GemOx vs 14.4 months with R-GemOx.²
• Among patients with primary refractory disease or early treatment relapse, the CR rates were 56.0% and 16.7% in the Glofit-GemOx and R-GemOx groups, respectively, with 3-year OS rates of 46.1% and 16.5%, respectively.²
• Glofit-GemOx demonstrated comparable efficacy outcomes across age subgroups, including patients aged ≥75 years.²
  • The rate of any grade cytokine release syndrome was slightly higher among patients aged ≥75 years (52.4% vs 44.8% for the overall Glofit-exposed population).²
• Overall, the safety profile was manageable, with no new safety signals and no evidence of cumulative toxicity or new long-term adverse events observed.²
• These data suggest that Glofit-GemOx is associated with high response rates, durable remissions, and prolonged survival, with a manageable safety profile, in transplant-ineligible patients with R/R DLBCL. Benefits were observed across subgroups, including patients with early treatment failure, as well as patients aged ≥75 years, subgroups representing patients with high unmet medical needs. 
• Results support the use of Glofit-GemOx, an off-the-shelf therapy, as a treatment option for transplant-ineligible patients with R/R DLBCL. 

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