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BMS pulls Opdivo+Yervoy combo in EU for advanced non-small cell lung cancer

Published on 03/02/20 at 12:08pm

Bristol-Myers Squibb has confirmed it has withdrawn its application with the European Commission for its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC).

The decision was made after the EMA’s Committee for Medicinal Products for Human Use (CHMP) informed the company that the data had submitted was not valid due to a number of “protocol changes” that had been made during the execution of the clinical study which generated them.

No other information was given to explain the move; BMS did confirm it had no plans to refile the application in Europe, but it remains under review by the FDA in the US.

The company did also state that it still intends to file applications for the combo with limited chemotherapy as a first-line therapy for lung cancer in the US< EU and beyond.

Filed in 2018, the original application concerned previously untreated NSCLC in patients with a tumour mutational burden ≥10 mutations/megabase, but was amended to include statistically significant overall survival data derived from patients whose tumours expressed PD-L1 ≥1%.

“CheckMate -227 is a robust Phase 3 study of more than 1,700 patients. 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,” commented Dr Samit Hirawat, Chief Medical Officer at BMS. “Patients with lung cancer should have access to innovative new therapies that offer the promise of long-term overall survival. We are continuing to advance our application in the U.S. for CheckMate -227 and plan to file data from CheckMate -9LA in markets globally to help address the serious unmet need in first-line lung cancer.”

Matt Fellows

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