Phase III POLARGO trial: Pola-R-GemOx vs R-GemOx in R/R DLBCL

Results from the open-label, multicenter, randomized, phase III POLARGO trial (NCT04182204), evaluating polatuzumab vedotin + rituximab + gemcitabine + oxaliplatin (Pola-R-GemOx; n = 129) vs rituximab + gemcitabine + oxaliplatin (R-GemOx; n = 126) in adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who were transplant-ineligible, were published in the Journal of Clinical Oncology by Matasar et al. The primary endpoint was overall survival (OS) in the intention-to-treat population.

Key data: The primary endpoint was met; after a median follow-up of 24.6 months, Pola-R-GemOx resulted in a 40% reduction in the risk of death vs R-GemOx (median OS, 19.5 months vs 12.5 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.43–0.83; p = 0.0017). Pola-R-GemOx also improved median progression-free survival (PFS; 7.4 months vs 2.7 months; HR, 0.37; 95% CI, 0.27–0.51; p < 0.0001) and complete response (CR) rates (40.3% vs 19.0%; p < 0.0001) vs R-GemOx. The most common Grade 3/4 adverse events (AEs) were thrombocytopenia and neutropenia. Thrombocytopenia (any grade) occurred in 53.1% of patients in the Pola-R-GemOx group vs 40.8% in the R-GemOx group (Grade 3/4, 34.4% vs 26.4%). Neutropenia (any grade) occurred in 41.4% vs 41.6% of patients (Grade 3/4, 33.6% vs 30.4%), respectively. Peripheral neuropathy was more frequent with Pola-R-GemOx vs R-GemOx (57% vs 28.8%) and was primarily Grade 1.

Key learning: Pola-R-GemOx demonstrated significant improvements in OS, PFS, and CR rates vs R‑GemOx in transplant-ineligible patients with R/R DLBCL, with no new safety signals identified, supporting Pola-R-GemOx as an additional treatment option for this patient population.