Bristol-Myers Squibb Gains NMPA Approval for Opdivo-Yervoy Combo in NSCLC

Bristol-Myers Squibb Gains NMPA Approval for Opdivo-Yervoy Combo in NSCLC

US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its immune checkpoint inhibitor combination of PD-1 inhibitor Opdivo (nivolumab) and CTLA-4 inhibitor Yervoy (ipilimumab). This approval is for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients with a PD-L1 tumor proportion score (TPS) greater than 1%, and without EGFR or ALK mutations.

Clinical Trial Basis
The approval is based on the CheckMate-227 study, one of the longest-term Phase III clinical trials evaluating NSCLC immunotherapy to date. The study demonstrated that Opdivo plus Yervoy provided long-term and continuous survival benefits. Specifically, 22% of patients with PD-L1>1% achieved six-year survival, compared to only 13% in the chemotherapy group. This combination also allowed patients to avoid the toxicity associated with chemotherapy.-Fineline Info & Tech