Another Opdivo setback for Bristol, this time on the combo front, widens Merck's immuno-oncology lead

Bristol-Myers won't be pursuing an accelerated first-line lung-cancer filing for its Opdivo-Yervoy combo, it said on Thursday.

So much for Bristol-Myers Squibb keeping pace in the first-line lung cancer combo market. After losing out to rival Merck on the monotherapy front, the New Jersey pharma giant is now falling further behind with its one-two punch, too.

On Thursday, Bristol-Myers announced that it would not be chasing an accelerated filing for its pairing of checkpoint inhibitor Opdivo and fellow immunotherapy Yervoy in the first-line space, a decision it based “on a review of data available at this time.” The company was mum on the details, citing an obligation to “protect the integrity of ongoing registrational studies.”

Bristol-Myers has been putting some extra emphasis on its combo potential since last August, when it revealed that Opdivo had unexpectedly flopped in a first-line monotherapy study. To rub salt in the wound, Opdivo nemesis Keytruda from Merck secured a monotherapy go-ahead from the FDA just a couple of months later.


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“My perspective is that this market will transition very rapidly through the data readouts of ’17 and ’18 into a combination market,” BMS CEO Giovanni Caforio reassured investors at the J.P. Morgan Healthcare Conference.

While that may be the case, it’s now Keytruda once again that stands in the best position to benefit, with Thursday’s news solidifying Merck’s combo lead. The company raised eyebrows last week with the surprise announcement that the FDA had accepted its application—for priority review, no less—for a new Keytruda-plus-chemo duo that could dramatically widen the drug’s market. And now, with players AstraZeneca and Roche also in the game, the question shifts from whether BMS can catch Merck to whether it can even hang on to second place.

“We … now increasingly think that Bristol will be facing a more crowded market when it formally launches,” Barclays analyst Geoff Meacham wrote in a note to clients, calling the No. 2 spot “a jump ball.”

AstraZeneca investors may not want to get too excited, though, Bernstein analyst Tim Anderson warned in his own investor note. Like Bristol-Myers, the British drugmaker is working to bring a pairing of a checkpoint inhibitor and a CTLA4 med to market. Thus, BMS’ setback “may raise concerns about the viability of the overall CTLA4 combination approach, given BMY's comment in its press release that the decision not to file early ‘is based on a review of data available at this time,’” Anderson wrote. “What ‘data’ is BMY referring to exactly?!”

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