An evaluation of sugemalimab for the treatment of relapsed or refractory extranodal natural killer T-cell lymphoma.

Introduction: Relapsed or refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) is a rare and aggressive subtype arising from natural killer or cytotoxic T-cells, predominantly affecting the nasal cavity and paranasal sinuses, lacking a standardized therapeutic approach. Sugemalimab, a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody (mAb), has been investigated in a Single-Arm, Multicenter, Phase II Study (GEMSTONE-201). The results demonstrated significant efficacy, favorable tolerability, and manageable adverse reactions of sugemalimab in R/R ENKTL. This study summarizes and compares the efficacy and safety profile of sugemalimab with several other PD-1/PD-L1 inhibitors in R/R ENKTL patients.

Area covered: We included a Phase II study (GEMSTONE-201) of sugemalimab in R/R ENKTL.

Expert opinion: The clinical trials have demonstrated superior efficacy of sugemalimab, evidenced by a complete response rate (CRR) of 35.9% and an overall response rate (ORR) of 44.9%. In comparison with other immune checkpoint inhibitors (ICIs), sugemalimab shows a notably higher CRR. Additionally, sugemalimab exhibits a manageable safety profile. Further evaluation of sugemalimab is required based on its efficacy and safety in real-world patient populations. Should sugemalimab be included in medical insurance in the future, it could potentially benefit a larger number of patients with R/R ENKTL.