Bristol-Myers' Study on Opdivo Halted on Early Success - Analyst Blog
Bristol-Myers Squibb Company BMY received encouraging news when its phase III study (CheckMate - 057) on intravenous human programmed death receptor-1 (PD-1) blocking antibody, Opdivo, was stopped early as an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study has met its endpoint. Bristol-Myers’ shares gained 2.6% following the announcement.
The phase III study evaluated Opdivo in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) in comparison to docetaxel. The study showed superior overall survival in patients receiving Opdivo as compared to the control arm.
Bristol-Myers is currently working to inform the eligible patients to continue or start treatment with Opdivo in an open-label extension study.
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.
Opdivo generated $5 million in its first few days in the market in the fourth quarter of 2014. Last month, the drug’s label was expanded for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy way ahead of the Prescription Drug User Fee Act date of Jun 22, 2015.
Our Take
We are pleased Bristol-Myers’ progress with Opdivo, one of the few anti PD-1 drugs to be approved in the U.S. In Sep 2014, Merck & Co.'s MRK Keytruda gained accelerated approval from the FDA for the treatment of patients suffering from advanced or unresectable melanoma who are no longer responding to other drugs. Keytruda was the first anti PD-1 drug to gain approval in the U.S.
Bristol-Myers already has a presence in the immuno-oncology space. Undoubtedly, Opdivo will significantly strengthen its position in this lucrative market. 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 are AVEO Pharmaceuticals, Inc. AVEO and Biogen Inc. BIIB. Both stocks carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
BRISTOL-MYERS (BMY): Free Stock Analysis Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
AVEO PHARMACEUT (AVEO): Free Stock Analysis Report
To read this article on Zacks.com click here.
