Bristol-Myers Squibb Company BMY announced positive data from a phase III, open-label, randomized study (CheckMate-017) evaluating Opdivo in comparison with Taxotere in treatment-experienced patients suffering from advanced squamous non-small cell lung cancer.
Bristol-Myers reported that CheckMate-017 proved that Opdivo was not only superior to standard-of-care chemotherapy in terms of overall survival but also had sustained benefits over time. One-year data showed an overall survival rate of 42% in the Opdivo arm versus only 24% in the Taxotere arm with a median overall survival of 9.2 months and 6 months, respectively.
We note that Opdivo is approved for the treatment of unresectable or metastatic melanoma in patients showing disease progression after receiving Yervoy and a BRAF inhibitor (if BRAF V600 mutation positive). Additionally, the drug is approved in the U.S. for the treatment of metastatic squamous non-small cell lung cancer patients whose disease has progressed on or after platinum-based chemotherapy.
Meanwhile, Opdivo is under review in the EU for the treatment of patients suffering from advanced (unresectable or metastatic) melanoma. Notably, in Apr 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the product for approval for this indication.
The above data was published in The New England Journal of Medicine and presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
Concurrently, Bristol-Myers announced results from another phase III study (CheckMate-067). The study evaluated Opdivo (plus Yervoy) or Opdivo (monotherapy) against Yervoy monotherapy in previously untreated advanced melanoma patients and showed that both the Opdivo-Yervoy regimen and Opdivo monotherapy were superior to Yervoy alone for progression-free survival. The study is ongoing with progression-free survival and overall survival as its co-primary endpoints.
Bristol-Myers carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Valeant Pharmaceuticals International, Inc. VRX, Actelion Ltd. ALIOF and Gilead Sciences Inc. GILD. All these stocks carry a Zacks Rank #1 (Strong Buy).
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