Multicenter phase 2 study of sugemalimab monotherapy for relapsed or refractory extranodal natural killer/T-cell lymphoma

Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is an aggressive type of non-Hodgkin lymphoma with limited treatment options. Sugemalimab is an anti-PD-L1 monoclonal antibody. The multicenter phase 2 GEMSTONE-201 study in China evaluated sugemalimab monotherapy for R/R ENKTL. The centrally assessed ORR was 44.9% (95% CI 33.6-56.6) with complete response in 35.9% of patients. Twelve month duration of response and overall survival rates were 82.5% and 67.5%, respectively. Most treatment-emergent adverse events were grade 1 or 2 in severity; grade ≥3 events were reported in 40.0% of patients. The authors conclude that sugemalimab showed robust and durable antitumor activity in R/R ENKTL. Treatment was well tolerated with expected safety profile for this drug class.