Bristol Myers Squibb Publishes Promising Phase 3 Data on New Opdivo Indication

Bristol Myers Squibb’s blockbuster drug Opdivo (nivolumab) has met its primary endpoint of event-free survival in a phase 3 trial compared to chemotherapy alone in patients with resectable nonsmall-cell lung cancer.

In addition to event-free survival, the 358-patient study is also evaluating several other endpoints, including pathologic complete response and overall survival. BMS said the data on overall survival was “favorable” but did not reach statistical significance, based on the early data.

Opdivo, an immunoglobulin G4 programmed death-1 inhibitor, got its initial FDA approval in 2014 and is FDA-approved for multiple indications, including melanoma, malignant pleural mesothelioma and colorectal cancer. BMS reported more than $7.5 billion in revenue for Opdivo in 2021.