Multicenter phase 2 trial of R2-GemOx-PD1i in relapsed or refractory diffuse large B-cell lymphoma

R2-GemOx-PD1i is a novel combination of the modified PD1 inhibitor penpulimab with lenalidomide and rituximab, gemcitabine, and oxaliplatin. A multicenter phase 2 trial in China evaluated R2-GemOx-PD1i for patients with refractory or relapsed diffuse large B-cell lymphoma (R/R DLBCL). Fifty-four patients received induction treatment of up to six cycles of R2-GemOx-PD1i at standard doses every two weeks, followed by pembrolizumab and lenalidomide as maintenance treatment (n=38) or autologous stem cell transplantation (ASCT) as consolidation (n=16). The primary endpoint was complete response rate after the induction phase. The overall response rate was 66.7%, with complete response in 57.4%. The median progression-free survival (PFS) was 30.4 months, and the median overall survival (OS) was not reached among all patients. Among the patients not receiving ASCT, the median PFS and OS were 21.2 months and not reached, respectively. Among the patients undergoing ASCT, median PFS and OS bothd were not reached. The most frequent treatment-related adverse events were neutropenia (66.6% of patients) and anemia (59.2%). Hypothyroidism was the most common immune-related adverse event (37.0%). The authors conclude that the R2-GemOx-PD1i regimen demonstrated encouraging activity with manageable toxicity in R/R DLBCL.