Sugemalimab approved in China as first-line treatment for gastric cancer – CStone Pharmaceuticals

CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China has approved the supplemental biologics license application (sBLA) for sugemalimab (Cejemly) in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression (Combined Positive Score [CPS] greater than 5).

Sugemalimab becomes the world’s first PD-L1 monoclonal antibody approved for this indication.

Dr. Jason Yang, CEO of CStone, said, “We are excited about the approval of sugemalimab in combination with chemotherapy in China as a first-line treatment for gastric cancer, which further underscored its clinical value and potential. Sugemalimab was previously approved in China for stage III and IV NSCLC, extranodal NK/T-cell lymphoma, and esophageal squamous cell carcinoma (ESCC). This approval marks the completion of sugemalimab’s achievement in all five indications that were taking into registration trials. We are working closely with the FDA andbEMA and other global regulatory bodies to explore registration pathways in these territories. We look forward to sugemalimab benefiting more cancer patients worldwide.”

Professor Lin Shen, Peking University Cancer Hospital, the leading principal investigator of the GEMSTONE-303 study said, “China is one of the countries with the highest burden of gastric cancer in the world. In clinical practice, most patients are already at a late stage when diagnosed with gastric adenocarcinoma, and those with unresectable or metastatic gastric cancer usually had poor prognosis and huge unmet medical needs. Sugemalimab is the world’s first anti-PD-L1 monoclonal antibody approved for the treatment of G/GEJ adenocarcinoma, providing a new treatment option for this population. We believe sugemalimab can be put into clinical use as soon as possible, offering new hope to more gastric cancer patients.”

This sBLA of sugemalimab was approved based on the data from the GEMSTONE-303 study. It is a multi-center, randomized, double-blinded, placebo-controlled Phase III registrational clinical trial, designed to evaluate the efficacy and safety of sugemalimab plus capecitabine and oxaliplatin (CAPOX) as a first-line treatment in patients with unresectable locally advanced or metastatic G/GEJ adenocarcinoma with PD-L1 expression greater than 5%. The co-primary endpoints were investigator-assessed PFS and OS. Secondary endpoints include blinded independent central review (BICR)-assessed PFS, investigator-assessed objective response rate (ORR), and duration of response (DoR). This study has met its pre-specified co-primary endpoints.