Bristol-Myers Squibb Company (NYSE:BMY) announced two-year overall survival data from two pivotal phase III studies – CheckMate -017 and CheckMate -057 – evaluating Opdivo versus Sanofi’s (NYSE:SNY) Taxotere (docetaxel) in previously treated metastatic non-small cell lung cancer. Data showed that Opdivo continued to demonstrate improved overall survival (OS), the primary endpoint for both studies, at the landmark two-year time point.
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In CheckMate -017, 23% of patients treated with Opdivo were alive at two years versus 8% of those treated with Taxotere. Median OS was 9.2 months with Opdivo versus 6 months with Taxotere. In CheckMate -057, 29% of patients treated with Opdivo were alive at two years compared to 16% of those treated with Taxotere. Median OS was 12.2 months with Opdivo versus 9.5 months with Taxotere. The safety profile of Opdivo at two years was found to be consistent with previous reports of data from both studies.
Bristol-Myers intends to present these data at the annual meeting of the American Society of Clinical Oncology next month. Findings to be presented at the meeting will also include additional research to explore biomarkers that may help predict outcomes with Opdivo.
We note that Opdivo is approved both in the U.S. and EU for several cancer indications. The drug recorded worldwide revenues of $942 million in 2015. Meanwhile, the company is working on expanding the drug’s label further. Opdivo is being evaluated for the treatment of various tumor types, alone or in combination with other approved cancer products such as Yervoy.
Early this week, Bristol-Myers announced that Opdivo gained FDA approval for the treatment of classical Hodgkin lymphoma in patients who have relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation Adcetris.
Label expansion should boost the drug’s commercial potential significantly.
Bristol-Myers is a Zacks Rank #1 (Strong Buy) stock. A couple of other top-ranked stocks in the health care sector are Retrophin, Inc. (NASDAQ:RTRX) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) , each sporting the same Zacks Rank as Bristol-Myers.
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