Gelonghui August 29th 丨Cornerstone Pharmaceutical-B (02616.HK) announced that the phase III study (GEMSTONE-303) of locally advanced or metastatic gastroesophageal adenocarcinoma with PD-L1 expression ≥ 5% that cannot be surgically removed in first-line treatment with sugarizumab combined with chemotherapy reached the main end point of overall survival (OS). Compared with the placebo plus chemotherapy control group, sugarizumab combined with chemotherapy can significantly prolong the overall survival time of patients, and the difference is statistically significant and clinically significant. Safety is consistent with previously reported clinical study results related to sugarizumab, and no new safety signals have been discovered.
Dr. Yang Jianxin, CEO and Executive Director of Cornerstone Pharmaceuticals, said, “We are pleased to see that suglizumab has proven its outstanding efficacy and clinical value in the first-line treatment landscape for gastric cancer. Previously, suglizumab had been successful in treating stage III and stage IV non-small cell lung cancer, esophageal cancer, and recurrent refractory extranodal NK/T cell lymphoma. Currently, China's National Drug Administration (NMPA) is reviewing the marketing application for new indications of sugarizumab combined with chemotherapy for first-line treatment of advanced gastric cancer. Sugarlimonab is expected to become the world's first PD-L1 monoclonal antibody approved for gastroesophageal joint adenocarcinoma indications. We also plan to communicate with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to explore global registration paths to bring sugarizumab, an innovative treatment to gastric cancer patients around the world.”
Professor Shen Lin of Peking University Cancer Hospital, the principal investigator of the sugarlizumab GEMSTONE-303 study, said, “Clinically, most gastric adenocarcinoma patients are already at an advanced stage when diagnosed and cannot be surgically removed. However, patients with advanced or metastatic gastric cancer usually have poor prognosis and unmet medical needs. Today, we are happy to see the GEMSTONE-303 study yielded positive OS results. Sugarizumab combined with chemotherapy significantly prolongs PFS and OS in patients with gastroesophageal junction adenocarcinoma, and is safe and tolerable. We are confident that sugarlizumab will bring much-anticipated new treatment options to this patient community in the future.”