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Bristol-Myers' Opdivo-Yervoy NSCLC Application in EU Withdrawn

Zacks Equity Research

Bristol-Myers Squibb Company BMY announced the withdrawal of its application in the European Union (EU) for the combination of anti-PD-1 antibody Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from the CheckMate-227 study. The application was initially filed in 2018 for patients with first-line NSCLC, who have tumor mutational burden.

However, the application was later amended to include the statistically significant overall survival data, a co-primary endpoint, from CheckMate-227 Part 1a, evaluating Opdivo plus Yervoy versus chemotherapy in patients whose tumors expressed PD-L1 ≥1% 

Per the company, Europe's Committee for Medicinal Products for Human Use (CHMP) stated that it was not possible to assess the data provided by the company because of "multiple protocol changes" it made in the study.

Bristol-Myers has no intention of refiling the application anytime soon. In January 2020, the FDA granted a Priority Review for the combination of Opdivo and Yervoy for the treatment of first-line NSCLC based on data from Part 1 of the phase III CheckMate -227 study.

Shares of Bristol-Myers have rallied 24.7% in the past year, outperforming the industry’s growth of 10.2%.


We note that Opdivo is currently approved in many countries, including the United States, the EU and Japan, for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. The Opdivo and Yervoy combination is approved for the treatment of patients with unresectable or metastatic melanoma and intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

The combination is also approved for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC), which has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

Label expansion of Opdivo into additional indications would lend the product access to a higher patient population and increase its commercial potential significantly.

However, the drug is facing competitive challenges in the United States from Merck’s MRK PD-L1 inhibitor, Keytruda,

Zacks Rank & Other Stocks to Consider

Bristol-Myers currently carries a Zacks Rank #3 (Hold). 

A few better-ranked stocks from the healthcare space are Pfizer, Inc. PFE and Roche Holding AG RHHBY. While Pfizer sports a Zacks Rank #1 (Strong Buy), Roche carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Pfizer’s earnings per share estimates have moved up from $2.62 to $2.77 for 2020 and from $2.73 to $2.81 for 2021 in the past 90 days. The company delivered a positive earnings surprise of 7.46%, on average, in three of the last four quarters.

Roche’s earnings per share estimates have increased from $2.61 to $2.66 for 2020 in the past 60 days.

Bristol-Myers Squibb Company Price


Bristol-Myers Squibb Company Price

Bristol-Myers Squibb Company price | Bristol-Myers Squibb Company Quote


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