CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R ENKTL), marking it as the first tumor immunotherapy for this condition.
Approval Based on GEMSTONE-201 Study
The approval is based on the results from the GEMSTONE-201 study, which assessed the efficacy and safety of sugemalimab in adult patients with R/R ENKTL. The study demonstrated that sugemalimab significantly improved the objective response rate (ORR) compared to historical controls. Among 78 evaluable patients, the Independent Radiological Review Committee (IRRC) assessed an ORR of 44.9%, with a complete response rate of 35.9%.
Safety and Efficacy Profile
Subgroup analysis indicated that sugemalimab had a broad range of efficacy in R/R ENKTL patients, including those who had received multiple lines of treatment, regardless of whether remission had been achieved on the front line. The tolerability and safety of sugemalimab in R/R ENKTL patients were good, with no new safety signals identified.
Previous and Pending Approvals
Sugemalimab, which was first approved in China in December 2021, has received approvals for use in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) and other indications. The drug is also awaiting regulatory decisions in China for use in first-line gastric/gastroesophageal junction adenocarcinoma, first-line esophageal squamous cell carcinoma, and is awaiting a decision in the UK for first-line NSCLC combined with chemotherapy.-Fineline Info & Tech
