The results call into question whether the drug, called Opdivo, will ever be effective for lung cancer patients that have been diagnosed recently. From Bloomberg:
In results presented Sunday at the European Society for Medical Oncology meeting in Copenhagen, Opdivo data showed it wasn’t superior to chemotherapy even in patients with high levels of a protein called PD-L1, which has been thought to be a predictor of how well the immune-system drugs will work. The data came from a detailed analysis of the Checkmate-26 study, whose main findings were released in August, causing Bristol-Myers’ stock to slump.
Opdivo is part of a group of cutting-edge drugs that use immunotherapy to attack cancer. The drug has already proven useful in certain types of cancer, but initial trials with lung cancer have proven ineffective.
The results were “below expectations,” wrote John Scotti, an analyst at Evercore ISI in New York. Imbalances in the trial, where more women and more people with high PD-L1 levels got chemotherapy, may have skewed the results, said Nick Botwood, the company’s development lead for lung cancer.
“The study was designed to ask a very specific question at the 5 percent expression,” Botwood said during a conference call after the data presentation. “It wasn’t designed to ask a question at 50 percent.” He was referring to a measure of how prominent the PD-L1 biomarkers are in a patient’s cancer — with 50 percent being considered a high level.
Today’s news follows a similar development back in August, when Opdivo failed an early trial. The company had hoped that Opdivo would prove more effective in subsequent studies.
BMY shares fell $3.85 (-6.95%) to $51.58 in premarket trading Monday. Prior to today’s news, BMY had already fallen 19.42%.