CStone Pharmaceuticals announced that the company has reported primary results from the registrational GEMSTONE-201 study of anti-PD-L1 antibody sugemalimab treating patients with relapsed or refractory extranodal natural killer cell/T-cell lymphoma (R/R ENKTL) as an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The GEMSTONE-201 study was designed to evaluate the efficacy and safety of sugemalimab as monotherapy for the treatment of adult patients with R/R ENKTL. As of November 10, 2021, 80 patients were enrolled in the GEMSTONE-201 study and received sugemalimab monotherapy. As of the data cutoff date, median follow-up duration was 13.4 months, and 23 patients remained on treatment with sugemalimab in this study. Key results of this study are the following: Results on the primary endpoint showed that sugemalimab significantly improved objective response rate (ORR) compared to historical controls. In 78 evaluable patients, ORR assessed by Independent Radiology Review Committee (IRRC) was 46.2% and the complete response (CR) rate reached 37.2%.; Based on the evaluation by IRRC, durable objective response was observed in patients who responded to sugemalimab. Median duration of response (DoR) was not reached at the time of the analysis. The 6-month and 12-month DoR rates were 90.8% and 86.0%, respectively.; Investigator-assessed efficacy was found highly consistent with IRRC evaluations. The concordance rate between investigator- and IRRC-assessed ORR reached 97.1%.; The analysis of overall survival (OS) showed a signal of OS benefit with sugemalimab as monotherapy in patients with R/R ENKTL; the OS rates at 6 months, 12 months and 24 months were 79.2%, 68.6% and 54.6%, respectively.; Sugemalimab also demonstrated a well-tolerated safety profile in patients with R/R ENKTL, and no new safety signals were observed.
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