Polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin in relapsed or refractory diffuse large B-cell lymphoma: results from the phase III, randomized POLARGO trial

A randomised, open-label, global phase 3 trial. After a 15-patient safety run-in, 255 patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or transformed from an indolent lymphoma, who were ineligible for autologous stem-cell transplantation, were randomised 1 to 1 to polatuzumab vedotin with rituximab, gemcitabine and oxaliplatin (129) or to rituximab, gemcitabine and oxaliplatin alone (126), every 21 days for up to eight cycles. Overall survival was the primary endpoint.

After a median follow-up of 24.6 months, the hazard ratio for death was 0.6 (95 per cent confidence interval 0.43 to 0.83, p = 0.0017), with median overall survival 19.5 months (13.3 to not estimable) against 12.5 months (8.9 to 15.8). The commonest grade 3 or 4 adverse events were thrombocytopenia and neutropenia. Peripheral neuropathy occurred in 73 patients (57 per cent) on the polatuzumab arm against 36 (29 per cent), and was primarily grade 1. Fatal adverse events occurred in 15 patients (12 per cent) against five (4 per cent), largely driven by infections including COVID-19.