Glofitamab + pola-R-CHP in newly diagnosed DLBCL and HGBCL: Phase II trial results

Results from a multicenter phase II trial (NCT05800366) evaluating glofitamab added to polatuzumab + rituximab + cyclophosphamide + doxorubicin + prednisone (pola-R-CHP) in 41 patients with newly diagnosed (ND) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) and an International Prognostic Index (IPI) ≥2 were published in Blood by Crombie et al. The primary endpoint was best complete response (CR) rate.

Key data: The best overall response rate (ORR) was 95% (95% CI, 83–99), with a best CR rate of 95% (95% confidence interval [CI], 83–99). At a median follow-up of 23.9 months, the 24-month progression-free survival (PFS) and overall survival (OS) were 95% (95% CI, 89–100%) and 98% (95% CI, 93–100%), respectively; median PFS and OS were not reached (NR). Grade 3/4 hematologic toxicities included neutropenia (66%), anemia (15%), and thrombocytopenia (15%). The most common non-hematologic toxicities included peripheral neuropathy (46%), nausea (44%), elevated alanine aminotransferase (ALT; 32%), diarrhea (32%), elevated alkaline phosphatase (24%), constipation (24%), fatigue (24%), and elevated aspartate aminotransferase (AST; 22%); all were Grade 1/2. Overall, 10% of patients developed cytokine release syndrome (CRS; all Grade 1); no immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.

Key learning: In this study, the addition of glofitamab to pola-R-CHP resulted in high CR rates, with no new safety signals reported, supporting further evaluation in larger randomized studies.