Bristol-Myers Squibb Company (BMY) announced that a phase III study on its intravenous anti-PD1 immune checkpoint inhibitor, Opdivo, was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint. We expect investors to react positively to the news.
The open-label, randomized phase III study, CheckMate – 017, compared the use of Opdivo versus Sanofi's (SNY) Taxotere (docetaxel) in previously treated patients with advanced or metastatic squamous cell non-small cell lung cancer (NSCLC). In the study, Opdivo demonstrated superior overall survival in patients as compared to Taxotere.
Last month, Opdivo was approved in the U.S. for the treatment of patients suffering from unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo gained accelerated approval for the melanoma indication based on tumor response rate and the durability of response. Full approval for this indication depends on verification and description of clinical benefit in the confirmatory trials (read more: Bristol-Myers Oncology Drug Opdivo Receives FDA Approval).
The candidate is under review in the EU for the advanced melanoma and NSCLC indications. The company is also looking to get Opdivo approved for NSCLC in the U.S. We expect investor focus to remain on updates regarding the high potential Opdivo.
Bristol-Myers carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. (AMAG) and Alexion Pharmaceuticals, Inc. (ALXN). Both stocks carry a Zacks Rank #1 (Strong Buy).
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