April 17, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Bristol-Myers Squibb Company is on another roll with blockbuster cancer drug Opdivo, saying Friday it had halted a large study because it had found that the drug was effective against the most common form of lung cancer, setting the stage for a broader battle for market share beyond its already approved lung cancer and melanoma indications.
Dubbed Checkmate-057, the study was ended early when an independent data monitoring committee concluded that Opdivo provided a survival advantage over the standard chemotherapy docetaxel. This particular study enrolled patients previously treated non-squamous non-small cell lung cancer. It was the second late-stage study of the drug to be halted for efficacy purposes.
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.
The news came as little surprise to analysts who follow the space, with Mark Schoenebaum, an analyst and medical doctor at ISI Evercore, saying in an early note that expectations for the drug remain high.
“Today’s announcement removes the risk (even if small) that the trial missed the interim analysis and needed to run to final analysis which could have opened the window to some degree for competitors, such as MRK which is expected to file in lung cancer mid-2015 (exact indication unknown),” he wrote in a note to investors.
The FDA gave breakthrough status to Opdivo breakthrough last May, and green-lit the drug to treat skin cancer in December 2014. How many more indications Bristol hopes to have approval for remains to be seen, said Schoenebaum, but it’s a built-in assumption that the company will attempt to grab as much market share as possible.
“So now with Checkmate-057 stopping early, the next question appears to be timing of FDA approval (stopping of Checkmater-017 was announced in mid-January, the BLA was accepted by FDA in late February and the FDA approved Opdivo in second line lung cancer in early March ’15, perhaps the fastest approval that in my 15 year career),” he wrote.
“But assuming near-term filing and approval a little ahead of regular priority review timelines, Opdivo could still receive approval by YE'15 and BMY could be on the market for all second line lung cancer (NSCLC) patients independent of PDL1 tumor expression by the beginning of 2016.”
Bristol-Myers Squibb Co. (BMY) in January had already halted a late-stage study of immunotherapy lung cancer drug Opdivo after it had shown so much success further study was superfluous.
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 & Co. ’s own PD-1 drug, Keytruda, continues to provide competition for BMY. Both Opdivo and Keytruda are approved to treat patients who have not responded to other treatments previously.
An analysis provided by NASDAQ said earlier this month that Merck and Bristol continue to battle for supremacy in this particular market.
“According to prescription data provided by Symphony Health, Merck‘s cancer drug Keytruda is growing fast, and is well ahead of Bristol-Myers Squibb‘s Opdivo in terms of sales. Opdivo’s sales stood at $3 million in February as compared to $24.8 million for Keytruda,” said the analysis.
“The latter drug’s sales have increased five-fold since its launch. However, Opdivo, which was initially launched for Melanoma, received FDA approval for lung cancer in early March and this can significantly expand its target market,” it said. “Merck expects to file for a similar indication later this year, which suggests that Opdivo has some time to close the gap and take a lead against Merck in immuno-oncology market which is currently dominated by Roche .”
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