Bristol's Opdivo Fails In Lung Cancer Test — Will It Keep Its Approval?

Bristol-Myers Squibb‘s (BMY) Opdivo likely will retain an accelerated approval to treat a form of lung cancer despite the failure of a late-stage study, an analyst said Friday.

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In August, Bristol’s Opdivo gained accelerated approval to treat small-cell lung cancer patients who relapsed after other treatments. Regulators can approve a drug that treats an unmet need on an accelerated basis. But the benefit must be confirmed in later studies.

Evercore analyst Umer Raffat doesn’t expect U.S. regulators to withdraw Opdivo’s go-ahead in this group of patients. Bristol’s study, called Checkmate-331, wasn’t the only study designed to confirm its benefit, he said in a report to clients.

“We saw a similar situation with Roche (RHHBY),” he said. Roche’s Tecentriq gained accelerated approval following an advanced bladder cancer study, but the confirming test failed. “But now, about 1.5 years later, (advanced bladder cancer) remains on the label.”

Hard-To-Treat Lung Cancer

In Bristol’s study, the pharmaceutical company tested cancer treatment Opdivo against the standard of care, chemotherapy. Opdivo didn’t improve overall survival vs. chemo in patients who relapsed after at least one round of chemo.

“Small-cell lung cancer is a highly aggressive disease in which significant unmet need remains,” Sabine Maier, Bristol’s development lead for thoracic cancer, said in a written statement. She noted Bristol is still researching lung cancer treatments.

Bristol is also studying Opdivo plus fellow cancer treatment Yervoy vs. Opdivo alone as a maintenance treatment for small-cell lung cancer patients whose cancer didn’t relapse after chemotherapy. That test is called Checkmate-451.

In early trading on the stock market today, Bristol stock dipped a fraction, near 57.30.

Bristol’s Failed Study

Evercore’s Raffat noted several issues with Bristol’s failed study. The initial test was in 480 patients. For most of 2017, the National Library of Medicine’s ClinicalTrials.gov showed about 560 patients. This August, that rose to about 800.

“It’s unclear whether we should have read into the trial upsizing,” Raffat said.

Further, other pharmaceutical companies are looking at their rival cancer treatments in chemotherapy combinations that tackle small cell lung cancer. Unlike its rivals, Bristol isn’t testing its cancer treatment in never-before-treated patients.

“I think Bristol has put itself at a competitive disadvantage by not having a clear (first treatment) trial,” he said. “Notice that Checkmate-451 is a maintenance trial, whereas Merck (MRK), Roche and AstraZeneca (AZN) are going right into treatment-naive SCLC.”

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