Latest updates from the phase III STARGLO trial: 2L and 3L+ data

The Lymphoma Hub was pleased to speak to Charles Herbaux, University of Montpellier, FR. Herbaux discussed the latest updates from the phase III STARGLO trial (NCT04408638) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), with a focus on second-line (2L) and third-line+ (3L+) data. 

Key points¹ 

• The 2:1 randomized, global, phase III STARGLO trial assessed the efficacy and safety of glofitamab (Glofit) + gemcitabine + oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with R/R DLBCL with ≥1 prior line of systemic therapy.
• Patients with one prior line of therapy must be ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT).
• In the primary analysis, Glofit-GemOx improved overall survival (OS), progression-free survival (PFS), and the complete response (CR) rate vs R-GemOx.
• An extended follow-up post hoc analysis evaluated the efficacy and safety outcomes in the STARGLO trial in patients with 1 or ≥2 prior lines of therapy.
• After a median follow-up of 24.7 months, Glofit-GemOx demonstrated a clinically meaningful OS, PFS, and CR benefit vs R-GemOx, irrespective of the number of prior lines of therapy.
• Glofit-GemOx improved the median OS vs R-GemOx in 2L patients (not reached vs 15.7 months; hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.40–1.02) and 3L+ patients (18.3 months vs 6.7 months; HR, 0.57; 95% CI, 0.34–0.95).
• Median PFS was longer with Glofti-GemOx vs R-GemOx in 2L patients (25.0 months vs 5.6 months; HR, 0.52; 95% CI, 0.32–0.83) and 3L patients (9.2 months vs 2.0 months; HR, 0.40; 95% CI, 0.24–0.66).
• The CR rates were higher with Glofit-GemOx vs R-GemOx in both 2L patients (63.5% vs 28.1%) and 3L patients (50.0% vs 20.6%).
• Results suggest that Glofit-GemOx offers higher efficacy outcomes in earlier lines of therapy.
• In terms of safety data, there were higher rates of infectious events in patients treated with Glofit-GemOx vs R-GemOx.
• It is important to assess whether a patient with R/R DLBCL is eligible for, or has access to, chimeric antigen receptor (CAR) T-cell therapy; for patients who cannot receive CAR T-cell therapy, these results suggest that Glofit-GemOx is a strong option after one or more lines of therapy.  

This educational resource is independently supported by Roche. All content is developed by SES in collaboration with an expert steering committee. Funders are allowed no influence on the content of this resource.