Bristol-Myers Squibb Co.'s Opdivo showed superior overall survival benefit compared to standard treatment in a phase 3 lung cancer trial with predominantly Chinese patients.
The CheckMate -078 trial evaluated Opdivo, also known as nivolumab, against Sanofi's Taxotere, also known as docetaxel, in patients with previously treated advanced non-small cell lung cancer. The trial was stopped early after meeting its main goal, confirming for the first time that nivolumab shows a superior overall survival benefit in Chinese patients, the company said.
Opdivo's safety profile was consistent with previous results in solid tumors.
Bristol-Myers said it has filed a biologics license application for the drug with the China Food and Drug Administration, and that it will evaluate the CheckMate -078 data with investigators for the presentation and publication of results.
CheckMate -078 was conducted primarily in China and included 504 patients who are predominantly Chinese. Lung cancer is the leading cause of cancer death in China.
Opdivo is approved by the U.S. FDA for multiple tumor types.
