Bristol-Myers Squibb Company announced that a Phase 3 study evaluating Opdivo versus docetaxel was stopped early because the study met its primary endpoint.
The CheckMate-078 study, conducted primarily in China, with additional study sites in Hong Kong, Russia and Singapore, involved patients who were previously treated for advanced or metastatic non-small cell lung cancer (NSCLC). The study showed that patients receiving Opdivo demonstrated superior overall survival benefit compared with those who received the standard chemotherapy treatment, docetaxel.
Based on these results, BMS submitted a Biologics License Application (BLA) for Opdivo to the China FDA for the proposed indication of previously treated NSCLC, which has been accepted by the CFDA.
If approved, Opdivo could become the first immuno-oncology treatment for previously treated lung cancer patients in China.
Read the press release