Bristol-Myers Squibb announced Friday that it has pulled its European application seeking approval of the PD-1 inhibitor Opdivo (nivolumab) plus CTLA-4 inhibitor Yervoy (ipilimumab) for the first-line treatment of advanced non-small-cell lung cancer (NSCLC) based on data from the CheckMate -227 trial. The company stated that it has no plans to refile this application in the EU.
The filing was originally submitted in 2018 for first-line NSCLC patients with high tumour mutational burden (TMB) based on the final analysis of progression-free survival, a co-primary endpoint in the trial. It was later amended to include data from Part 1a of CheckMate -227, evaluating Opdivo plus Yervoy versus chemotherapy in patients with at least 1% PD-L1 expression, with results showing the combination significantly improved the co-primary endpoint of overall survival (OS).
According to Bristol-Myers Squibb, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) "acknowledged the integrity of the patient level data," but found that a "full assessment of the application was not possible following multiple protocol changes the company made in response to rapidly evolving science and data." Samit Hirawat, chief medical officer at the drugmaker, said "the durable survival benefit seen in CheckMate -227 is an important result for patients and we are disappointed with the CHMP's position."
Still, Bristol-Myers Squibb said it is "committed to first-line lung cancer patients in Europe, the US and other markets," with a planned filing of results from the CheckMate -9LA trial, which showed that Opdivo plus low-dose Yervoy met the primary endpoint of superior OS for first-line patients with advanced NSCLC, regardless of PD-L1 expression and histology.
Meanwhile, a US application for Opdivo plus Yervoy is currently under priority review based on data from Part 1 of the CheckMate -227 study for use in first-line patients with metastatic or recurrent NSCLC who don't have EGFR or ALK genomic tumour aberrations. The US regulator is expected to decide on the combination by May 15. Bristol-Myers Squibb had withdrawn its US application in January last year, saying it was waiting for final data from Part 1a of Checkmate -227, which wasn't going to be available in time for the FDA's original action date.
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