Bristol-Myers Squibb Company BMY announced encouraging results from a phase II study (CheckMate -069) on intravenous human programmed death receptor-1 (PD-1) blocking antibody, Opdivo in combination with Yervoy as compared to Yervoy alone in patients suffering from previously untreated advanced melanoma.
Results revealed that patients treated with the combination regimen showed a much higher objective response rate (ORR) of 61% as compared to 11% in those under Yervoy monotherapy. This was also the primary endpoint of the study. Complete responses were also statistically higher in patients under the combination regimen as compared to those under Yervoy monotherapy.
The company said that the safety profile was consistent with previous studies on the Opdivo plus Yervoy regimen.
Bristol-Myers intends to present these data at the American Association for Cancer Research Annual Meeting. The results are also expected to be published in The New England Journal of Medicine.
Bristol-Myers has in fact been riding high on the back of Opdivo ever since the drug 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 non-small cell lung cancer with progression on or after platinum-based chemotherapy way ahead of the Prescription Drug User Fee Act date of Jun 22, 2015.
Bristol-Myers shares were also up last week when its phase III CheckMate – 057 study on Opdivo was stopped early based on an assessment conducted by the independent Data Monitoring Committee. It concluded that the study has met its endpoint.
We expect investor focus to remain on 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 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).
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