POLARGO trial: Pola-R-GemOx vs R-GemOx in patients with R/R DLBCL

Polatuzumab vedotin, a CD79b-directed antibody–drug conjugate, is approved for the treatment of first-line and relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).¹ The open-label, multicenter, randomized, phase III POLARGO trial (NCT04182204) assessed the safety and efficacy of polatuzumab vedotin in combination with rituximab + gemcitabine + oxaliplatin (Pola-R-GemOx) vs rituximab + gemcitabine + oxaliplatin (R-GemOx) in transplant-ineligible patients with R/R DLBCL (N = 255).¹ Results from this trial were presented during the European Hematology Association (EHA) 2025 Congress, June 12–15, 2025, Milan, IT, by Matthew Matasar.¹ The primary endpoint was overall survival (OS), and key secondary endpoints included progression-free survival (PFS), complete response (CR) rate, and overall response rate (ORR).¹

Key learnings

At a median follow-up of 24.6 months, the median OS was prolonged with Pola-R-GemOx compared with R-GemOx (19.5 months vs 12.5 months; stratified HR, 0.60; 95% CI, 0.43–0.83; p = 0.0017). Survival benefit was observed across subgroups, including ABC and GCB cell of origin subgroups.

Pola-R-GemOx showed improved median PFS compared with R-GemOx (7.4 months vs 2.7 months; stratified HR, 0.37; 95% CI, 0.27–0.51; p < 0.0001). The ORR (52.7% vs 24.6%) and CR rates (40.3% vs 19.0%) were also higher with Pola-R-GemOx vs R-GemOx.

The safety profile of Pola-R-GemOx vs R-GemOx was consistent with the known safety profile of the individual agents, including infections (any grade, 41.4% vs 31.2%; Grade ≥3, 21.9% vs 9.6%) and peripheral neuropathy (any grade, 57.0% vs 28.8%; Grade 3, 3.9% vs 0%).

Results from the POLARGO trial suggest that Pola-R-GemOx is an effective alternative treatment option for transplant-ineligible patients with R/R DLBCL.