Bristol-Myers reports 'positive' results from Phase 3 CheckMate -078 trial
Bristol-Myers announced results from the pivotal, randomized Phase 3 CheckMate -078 trial evaluating Opdivo versus docetaxel in a predominantly Chinese population with previously treated advanced non-small cell lung cancer. In the study, Opdivo demonstrated a statistically significant benefit versus docetaxel on the primary endpoint of overall survival. An OS benefit was observed regardless of PD-L1 expression or tumor histology. Additionally, the two secondary endpoints of objective response rate and median duration of response demonstrated durability with Opdivo compared with docetaxel. In CheckMate -078, Grade 3-4 treatment-related adverse events occurred less frequently with Opdivo versus docetaxel (10% vs 47%). Discontinuation due to Grade 3-4 TRAEs were less frequent with Opdivo (3%) than with docetaxel (5%). Findings will be presented on Monday, April 16 from 4:05-4:20 PM CDT during the Updates in Immuno-Oncology Trials session at the American Association for Cancer Research Annual Meeting 2018 in Chicago.