Bristol Myers Squibb's Novel Dual-Agent Cancer Therapy BMS-986489 Granted IND Approval in China for Small Cell Lung Cancer

Mar 13, 2025 10:20 CST Updated 10:20

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The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration recently announced that Bristol-Myers Squibb Company has applied for a Class 1 new drug.BMS-986489 (BMS-986012 + nivolumab fixed-dose combination)Injection solution receives implied permission for clinical trials, intended for development as a treatmentPatients with Small Cell Lung Cancer (SCLC). Public information shows that this is aAnti-Fucosyl-GM1 Monoclonal AntibodyBMS-986012 and Anti-PD-1 Monoclonal Antibody NivolumabThe fixed-dose combination has entered the Phase 3 clinical research stage internationally.。

Screenshot source:CDE Official Website

Ganglioside Focusyl-GM1 (FucGM1) is a tumor-associated antigen,Expressed in approximately 50% to 90% of SCLC tumors, but with limited expression in normal tissues., making it a promising target in immuno-oncology.

According to the public information released by Bristol-Myers Squibb, BMS-986012 is a novel, fully human IgG1 antibody that specifically binds to FucGM1. In preclinical studies,The product showed expression ofFucGM1Antibody-dependent cellular cytotoxicity (ADCC) of tumor cell lines. Tumor cell killing mediated by this product was also observed in complement-dependent cytotoxicity (CDC) and antibody-dependent cellular phagocytosis (ADCP) assays.. When BMS-986012 is used in combination with anti-PD-1 antibody, the therapeutic effect is significantly improved.

▲Introduction to Anti-FucGM1 Monoclonal Antibody (Screenshot source: Bristol-Myers Squibb official website)

BMS-986012 in combination withNivolumabPreviously demonstrated positive antitumor efficacy in early clinical studies for SCLC. At a median follow-up of 17.2 months, BMS-986012 + nivolumab + chemotherapy (n=67) was compared with nivolumab + chemotherapy (n=66).The median progression-free survival (PFS) was 5.8 months and 5.1 months, respectively, the median overall survival (OS) was 15.6 months and 11.4 months, respectively, and the 12-month OS rates were 67% and 48%, respectively.

According toClinicalTrialsOn the official website, Bristol-Myers Squibb has registered two clinical studies for BMS-986489, one of which is an international multicenter (including China) Phase 3 clinical study aimed at evaluating BMS-986489 in combination with carboplatin + etoposide compared to an anti-PD-L1 antibody in combination with carboplatin + etoposide, asFirst-line treatment for patients with extensive-stage small cell lung cancerEfficacy and safety (TIGOS study), which is currently recruiting and is expected to enroll 530 participants globally; a Phase 1 clinical study in China, aimed at evaluating BMS-986489 inChinese Patients with Relapsed/Refractory Small Cell Lung CancerSafety, tolerability, pharmacokinetics, and preliminary efficacy in China.

This timeBMS-986489Approval for clinical trials in China means that this product is about to formally commence clinical research in China.。

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Mar 10, 2025, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Bristol-Myers Squibb Official Website ESMO 2024 Investor Presentation. From https://www.bms.com/assets/bms/us/en-us/pdf/investor-info/doc_presentations/2024/ESMO-2024-investor-presentation.pdf

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