Glofitamab plus GemOx vs Rituximab-GemOx for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (STARGLO): A Global Phase 3 Trial

Overview

• Study Title: Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO)
• Journal: The Lancet
• Type: Global phase 3, randomised, open-label trial
• URL: The Lancet

Study Background

• Condition: Relapsed or refractory diffuse large B-cell lymphoma
• Treatment Options:
  • Glofitamab plus GemOx (Glofit-GemOx)
  • Rituximab plus GemOx (R-GemOx)
• Objective: To assess efficacy and safety of Glofit-GemOx compared to R-GemOx as a second-line therapy

Methodology

• Design: Randomised, open-label
• Participants: Transplant-ineligible patients
• Locations: 62 centers across 13 countries in Asia, Australia, Europe, North America
• Randomisation: 2:1 ratio for Glofit-GemOx and R-GemOx
• Stratification: Based on previous lines of therapy and relapse status
• Primary Endpoint: Overall survival
• Study Duration:
  • Primary analysis cutoff: March 29, 2023
  • Updated analysis cutoff: February 16, 2024

Key Results

• Participants: 274 patients (183 to Glofit-GemOx, 91 to R-GemOx)
• Demographics: 58% male, median age 68 years
• Primary Analysis:
  • Median follow-up: 113 months
  • Improved overall survival with Glofit-GemOx vs R-GemOx
  • Hazard Ratio (HR): 0.59
• Updated Analysis:
  • Median follow-up: 207 months
  • Continued survival benefit with Glofit-GemOx
  • HR: 0.62
• Safety:
  • Adverse events in 100% of Glofit-GemOx group, 96% of R-GemOx
  • Cytokine release syndrome in 44% of glofitamab patients, mostly low grade
  • Deaths related to treatment: 3% in Glofit-GemOx group and 1% in R-GemOx group

Interpretation

• Efficacy: Glofit-GemOx significantly improves overall survival vs R-GemOx
• Recommendation: Supports use in transplant-ineligible patients with relapsed or refractory diffuse large B-cell lymphoma

Funding

• Funded by F Hoffmann-La Roche

References

1. Susanibar-Adaniya, S & Barta, SK. Review of diffuse large B-cell lymphoma. Am J Hematol. 2021; 96:617-629.
2. Gisselbrecht, C & Van Den Neste, E. Management strategies. Br J Haematol. 2018; 182:633-643.
3. Tilly, H et al. Polatuzumab vedotin study. N Engl J Med. 2022; 386:351-363.
4. Kamdar, M et al. TRANSFORM interim analysis. Lancet. 2022; 399:2294-2308.
5. Locke, FL et al. Axicabtagene ciloleucel. N Engl J Med. 2022; 386:640-654.

These notes cover the highlights and key data points of the study, which measures the effectiveness of Glofitamab plus GemOx against Rituximab-GemOx in treating relapsed or refractory diffuse large B-cell lymphoma.