Bristol Myers (NYSE:BMY)
On August 5, 2016 Bristol Myers had a very rough day with respect to one of its targets in the pipeline. The company’s PD-1 immune checkpoint inhibitor, known as Opdivo, failed to meet the primary endpoint of a phase 3 clinical trial. Bristol Myer’s stock did not have a good day after the news was released. With investors digesting the news, the stock tanked by 16% during the trading day. This makes sense of course because that’s how the biotech world works. The phase 3 trial is the most crucial trial in the industry, because it dictates whether or not the company can seek FDA approval to market the drug.
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The phase 3 trial was known as CheckMate-026, and it treated patients with advanced non-small cell lung cancer — NSCLC. The trial recruited a total of 541 patients who were randomized to either receive 3 mg/kg of Opdivo, or a chemotherapy by choice of the physician. One note about the recruitment process of the trial, is that patients had to have at least 5% or greater expression of PD-1 in their tumor to receive treatment. The primary endpoint of the trial was looking for Progression-free survival — PFS. The measure of PFS is how long a patient lasts on treatment without the cancer getting worse.
Of course, Opdivo failed to improve progression-free survival in these patients with advanced NSCLC. Opdivio was being tested as a monotherapy for first-line patients in this indication. The company states that it will evaluate the full results, and them present them sometime in the near future. The CEO of Bristol Myers had this to say:
“While we are disappointed CheckMate-026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase III CheckMate-227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.”
Bristol Myers is still in good shape, because as noted in the quote above it is still in the process of targeting advanced NSCLC in PD-1 positive patients. This trial is known as CheckMate-227 and is using both two of the company’s drugs. The two drugs to be tested together are Opdivo and Yervoy. If this combination ends up being successful than Bristol Myers can redeem itself from this trial failure.
With Bristol Myers failing the phase 3 trial, it gave more leverage to big pharma competitor Merck. As soon as the news was announced Merck traded higher by 10%, because it had announced positive results for Keytruda in the similar indication. The trial for Merck had the same indication but patients in that clinical trial had PD-1 expression of 50% or more. Not only did Merck meet the primary endpoint of the study, but it also met the secondary endpoint of overall survival.
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It’s not to say that Bristol Myers will feel much pain on just failing this single trial. That is because Opdivo has already been approved for many indications. The first indication the drug was approved for was Melanoma back in December of 2014. A few other indications Opdivo is approved for is advanced renal cell carcinoma, and Hodgkin Lymphoma. Bristol Myers may have suffered a minor setback, but considering that it has Opdivo already approved for many other indications it is still in good shape. Moving forward the company’s stock should do great over the long-term.
[Image Courtesy of Wikipedia]