Bristol-Myers Squibb Company Study Halted After Opdivo Meets Efficacy Endpoint
Published: Jan 13, 2015
January 12, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Shares of Bristol-Myers Squibb Co. were up more than 6 percent in morning trading Monday after the company said it had halted a late-stage study of immunotherapy lung cancer drug Opdivo after it had shown so much success further study was superfluous.
Opdivo (nivolumab) is PD-1 inhibitor that uses the body’s own immune system to help target and destroy tumors. Bristol-Myers said it stopped the trial early because the study had met its primary endpoint and had shown a survival advantage that was significant enough to review the data and perhaps push into regulatory approval faster than expected.
Bristol-Myers had parsed the data from a randomized lung cancer study pitting Opdivo against chemotherapy drug docetaxel, and found a better survival rate for the 272 patients who got doses of Opdivo every two weeks, compared to docetaxel every three.
“CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival,” said the company in a statement. “The company will complete a full evaluation of the final CheckMate -017 data and work with investigators on the future presentation and publication of the results.”
In related news, competitor Merck said Monday that its own PD-1 drug, Kytruda, which was the first anti-PD drug approved by the U.S. Food and Drug Administration in September, could soon be approved for more uses. Merck said Monday it is on track to ask the FDA for a biologics license for Keytruda to treat additional types of small lung cancer. Both Opdivo and Keytruda are approved to treat patients who have not responded to other treatments previously.
Merck made the announcement ahead of the opening of the J.P. Morgan Healthcare Conference which begins Monday in San Francisco and the oldest and largest conference of its type. It will include 300 of the largest biotech, healthcare and biopharma companies presenting their top-line data and estimates to a sea of eager bankers, analysts, institutional investors, hedge funds and journalists.
The FDA gave breakthrough status to Opdivo breakthrough in May, and green-lit the drug to treat skin cancer last month.