Bristol-Myers Lung-Cancer Drug Disappoints in Trial Analysis

  • Drugmaker says trial design may have influenced negative data
  • Bristol-Myers results contrast with Merck’s in similar group

Bristol-Myers Squibb Co.’s immune-based therapy Opdivo fell short of already low expectations in study results that throw into question whether the drug can help lung-cancer patients who’ve just been diagnosed.

Opdivo 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, Bristol-Myers said in results presented Sunday at the European Society for Medical Oncology meeting in Copenhagen. The data came from a detailed analysis of the Checkmate-26 study, whose main results were released in August, causing Bristol-Myers’ stock to slump.

The results were in stark contrast to the performance of Merck & Co.’s Keytruda in a similar group of patients. Merck’s entire trial was designed around people with high PD-L1 levels, while Bristol-Myers tried to reach a wider range of patients. Bristol-Myers had already announced in August that Opdivo didn’t help the broader group. Sunday’s results showed the treatment didn’t aid the narrower group either.

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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.

Sam Fazeli, an analyst with Bloomberg Intelligence, said Bristol-Myers shouldn’t be written off just yet.

“No one believes that Opdivo is dead in first line,” Fazeli said in an e-mail. “It’s a drug that has worked in many settings. It’s just that the trial had so many aspects that apparently worked against it.”

Merck and Bristol-Myers have been battling for dominance in the new field of immune-oncology, in which medicines are designed to boost the body’s own defenses against cancer. Both drugmakers’ medicines are already approved for people whose lung cancer got worse after initial treatment. The trials presented Sunday would form the basis for approval or rejection as an initial treatment in lung cancer, a much bigger group of potential patients, and could be good news for Merck.

“With the right tactical moves, Merck can turn Keytruda into the broadest offering in lung cancer,” said Tim Anderson, an analyst with Sanford C. Bernstein & Co.

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