Bristol-Myers Squibb already has one Opdivo approval in previously treated head and neck cancer, but it won’t make that two.
The company, which was testing its immuno-oncology star alongside Yervoy in previously treated patients whose disease had recurred or spread, said Thursday that the pair had failed to outdo Opdivo on its own.
For now at least, Bristol isn’t sharing details on the phase 2 miss. But one thing is clear: The regimen won’t be backing up Opdivo in second-line head and neck cancer, where it’s currently battling Merck’s Keytruda.
It’s not the first time I-O drugmakers have stumbled in head and neck cancer. Back in July of 2017, BMS archnemesis Merck revealed that Keytruda, which was the first drug into the head and neck arena, had failed a confirmatory trial—though, as the company later explained, it was a narrow miss. A victory in previously untreated patients, though, was enough to convince regulators to keep Merck’s second-line approval intact.
Unfortunately for Bristol, that same victory also set Keytruda up for a first-line green light that will shrink Opdivo’s patient pool. Those treated first with Keytruda won't be eligible for Opdivo later—and that means a dwindling sales opportunity for Opdivo. In February, the FDA bestowed its priority review tag on Keytruda, so that challenge could come sooner rather than later.
Head and neck cancer also isn’t the first area in which Bristol has run into problems with its Opdivo-Yervoy combo. The drugmaker is still hoping to take the regimen into the front-line lung cancer market, but earlier this year it withdrew its FDA application for that approval, citing a need for more data. Merck, meanwhile, is sucking up market share on the back of major survival results that cemented Keytruda as the top PD-1/PD-L1 player in the class.