Bristol-Myers Squibb has announced the withdrawal of 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).
The application, based on data from CheckMate -227, was initially filed in 2018 for patients with first-line NSCLC who have tumour mutational burden ≥10 mutations/megabase, based on the final analysis of progression-free survival, a co-primary endpoint in the trial.
It was then subsequently amended to include the statistically significant result of overall survival, a co-primary endpoint, from CheckMate -227 Part 1a.
CheckMate -227 is a “robust Phase III study of more than 1,700 patients,” explained Samit Hirawat, chief medical officer, Bristol-Myers Squibb. “Opdivo plus Yervoy demonstrated a statistically and clinically significant overall survival benefit compared to chemotherapy for patients with first-line NSCLC. The durable survival benefit seen in CheckMate -227 is an important result for patients and we are disappointed with the CHMP’s position.”
In January 2020, the US Food and Drug Administration (FDA) granted a Priority Review for the combination of Opdivo and Yervoy for the treatment of first-line NSCLC.
Back in June last year, the combination demonstrated a clear trend towards improvement in overall survival compared to Bayer’s Nexavar (sorafenib) in unresectable hepatocellular carcinoma (HCC), as well as positive results in metastatic castration-resistant prostate cancer back in February.
