BMS' second small-cell trial flop endangers Opdivo lung cancer approval: analyst

Bristol-Myers Squibb’s Opdivo has failed another small-cell lung cancer trial—and now, its Yervoy combination approval in the disease could be in jeopardy.

Late Monday, the New Jersey drugmaker said a combination of Opdivo and fellow checkpoint inhibitor Yervoy had failed to show it could extend the lives of extensive-stage SCLC patients who had wrapped up an initial course of platinum-based chemotherapy. And coupled with an October trial flop, that’s a problem, Evercore ISI analyst Umer Raffat wrote in a note to clients.

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That trial, dubbed CheckMate-331, was supposed to confirm an approval the FDA doled out for Opdivo in previously treated SCLC back in August. And when that one came up short, “there was an expectation” that the most recent study—CheckMate-451—could “act as confirmatory,” he wrote, adding, “it didn’t work.”

Now, it’ll be up to the FDA to decide whether it wants to keep Opdivo’s green light for previously treated patients. And in the meantime, Roche’s Tecentriq is in line to become the immuno-oncology agent used earliest in SCLC treatment after posting positive results earlier this year.

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Those results came in the first-line setting, where Roche tested Tecentriq alongside chemo in previously untreated patients, as opposed to Bristol, which tested Opdivo as maintenance treatment post-chemo. “It’s unclear what thought process BMS used internally in deciding not to have a clear 1L SCLC trial,” Raffat wrote.

Whatever the reasoning, Bristol will now sit on the outside looking in as Roche queues up for what analysts have said could be a billion-dollar-plus boost to sales. Both companies are seeking out lung cancer niches as Merck & Co., which boasts PD-1 steamroller Keytruda, continues to dominate the non-small-cell lung cancer market.