Bristol-Myers Squibb Company BMY announced encouraging 18-month survival data from the phase III CheckMate – 057 study on the intravenous anti-PD1 immune checkpoint inhibitor, Opdivo. The open-label, randomized phase III study, CheckMate – 057, compared the use of Opdivo versus Sanofi's SNY Taxotere (docetaxel) in treatment-experienced patients with advanced, non-squamous non-small cell lung cancer.
In the study, Opdivo continued to demonstrate superior overall survival (OS) at 18 months. In the Opdivo arm, approximately 39% of patients were alive at 18 months versus 23% for Taxotere, based on a minimum follow-up of 17.1 months.
The company has submitted regulatory application for the drug for the above mentioned indication in both the U.S. and EU. The supplemental Biologics License Application for Opdivo was accepted with priority review by the FDA. Opdivo also enjoys breakthrough therapy designation for this indication.
Meanwhile, the company announced positive data from the phase III CheckMate – 025 study comparing Opdivo to Afinitor (everolimus) in advanced renal cell carcinoma patients after prior anti-angiogenic treatment, showing a significant OS benefit for Opdivo. In the study, median OS was 25 months in the Opdivo arm compared to 19.6 months for Afinitor.
We remind investors that earlier this year, the CheckMate – 025 study was stopped early after the independent Data Monitoring Committee concluded that the study demonstrated superior overall survival compared to Afinitor, thereby meeting the endpoint.
Apart from the above mentioned indication, the company is also working on including data from the CheckMate – 067 study on Opdivo in combination with Yervoy in patients with previously untreated advanced melanoma. The FDA has accepted the company’s supplemental biologics license application for the same and granted priority review. The FDA is expected to render a final decision by Jan 23, 2016.
Opdivo is currently approved for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation-positive, a BRAF inhibitor.
Opdivo generated revenues of $122 million in the second quarter of 2015 as compared to $40 million in the first quarter of 2015. Meanwhile, the company continues to work on the label expansion of the drug.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN. Both stocks hold a Zacks Rank #1 (Strong Buy).
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