Bristol Myers Squibb's (BMY.US) cancer combination therapy has been approved for clinical trials in China.

The National Medical Products Administration's Center for Drug Evaluation and Research (CDE) recently updated its website to show that BMS-986489 (BMS-986012+nivolumab fixed-dose combination) injection, a new drug application submitted by Bristol-Myers Squibb (BMY.US), has been granted a clinical trial permit for the development of small cell lung cancer (SCLC) patients. Public information shows that it is a fixed-dose combination of BMS-986012, an anti-Fucosyl-GM1 monoclonal antibody, and nivolumab, an anti-PD-1 monoclonal antibody, which has entered the third phase of clinical trials in the international community. Neurofucosyl-GM1 (FucGM1) is a tumor-associated antigen expressed in about 50%~90% of SCLC tumors but limitedly expressed in normal tissues, making it a promising target in immunotherapy. According to the public information of Bristol-Myers Squibb, BMS-986012 is a novel, fully human IgG1 antibody that specifically binds to FucGM1. In preclinical studies, the product showed antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cell lines expressing FucGM1. In complement-dependent cytotoxicity (CDC) and antibody-dependent cell phagocytosis (ADCP) experiments, tumor cell killing mediated by the product was also observed. When used in combination with anti-PD-1 antibody, the therapeutic effect was significantly improved.