BMS withdraws its application in the EU for Opdivo + Yervoy combination for the treatment of advanced NSCLC.

Bristol-Myers Squibb Company announced that the company has withdrawn its application in the European Union (EU) for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227. The application was originally filed in 2018 for patients with first-line NSCLC who have tumor mutational burden ?10 mutations/megabase, based on the final analysis of progression-free survival, a co-primary endpoint in the trial.

The application was subsequently amended to include the statistically significant result of overall survival, a co-primary endpoint, from CheckMate -227 Part 1a evaluating Opdivo plus Yervoy versus chemotherapy in patients whose tumors expressed PD-L1 greater than 1%.

Though the Committee for Medicinal Products for Human Use (CHMP) acknowledged the integrity of the patient level data, the CHMP determined a full assessment of the application was not possible following multiple protocol changes the company made in response to rapidly evolving science and data. The company has no plans to refile this application in the EU.