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Source: Guanlan Pharmaceutical
On April 10th, Bristol-Myers Squibb Company (BMS) announced the main results of the key phase 3 study of the CheckMate -649 China subgroup.
In a clinical study of immunotherapy for gastric cancer and gastroesophageal junction cancer covering patients in mainland China, the CheckMate-649 study is the first and currently the only first-line treatment phase 3 study with positive results.
As a PD-1 inhibitor directly involved in the development of Nobel Prize winners in Physiology or Medicine, Odivo has been approved as the world’s first PD-1 immunotherapy in July 2014 and has been approved for more than ten worldwide Cancer indications include lung cancer, head and neck cancer, stomach cancer, esophageal cancer, liver cancer, kidney cancer, colorectal cancer, urothelial cancer, melanoma, Hodgkin’s lymphoma, pleural tumors, etc.
In China, Odivo is also the first immuno-oncology drug approved.
CheckMate -649 is a phase 3 randomized, multicenter, open-label clinical study designed to evaluate the use of nivolumab combined with chemotherapy or nivolumab combined with ipilimumab compared with chemotherapy alone Efficacy of HER2-negative, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma who has not received previous treatment.
The results of the study showed that in patients with PD-L1 positive and CPS ≥ 5, the median OS of the Odivo combined chemotherapy group was 15.
In PD-L1 positive patients with CPS≥1 and all randomized populations, Odivo combined with chemotherapy also showed clinically significant OS benefits.
In this study, the safety characteristics of Odivo combined with chemotherapy are consistent with the known safety characteristics of Odivo and chemotherapy, and no new safety signals have been observed.