CheckMate-451: Bristol-Myers’ Opdivo — plus Yervoy — fails PhIII combo lung cancer study, the latest in a series of setbacks

Bristol-Myers Squibb $BMY is becoming well practiced at disappointing investors with their R&D strategy for lung cancer.

After the market closed Monday the pharma giant reported that their Phase III trial matching Opdivo and their CTLA-4 drug Yervoy for CheckMate-451 failed on the primary endpoint for overall survival. Researchers were studying the combination as a maintenance therapy for small cell lung cancer after a first round of chemo, and this was one of the late-stage studies that analysts have been waiting for.

Thomas Lynch, CSO at Bristol-Myers Squibb, at a June 2018 Endpoints News panel in Boston
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The failure follows close on the heels of another Phase III flop for their CheckMate-331 study, where Opdivo was unable to beat the standard of care for treating second-line small cell lung cancer.

Cowen calls this a hard hit for Bristol-Myers.

The failure of CM-451 is a significant miss for BMY. Without a 1L Opdivo + chemo combination study as part of the development strategy, it appears BMY is out of near-term opportunities to advance Opdivo into 2L therapy or 1L maintenance.

Bristol-Myers restricted themselves to a brief top-line announcement today, saving the actual data for later. Their stock dropped close to 3% in after-market trading.

Bristol-Myers’ setback comes just two months after Roche scored on IMpower133 in SCLC. The key metrics: Tecentriq plus chemo hit a median overall survival rate of 12.3 months compared to 10.3 months for chemo alone — a significant 30% drop in the risk of death. The PFS hit 5.2 months versus 4.3 months with a hazard ration of a more modest 0.77. That’s not phenomenal, but it’s an improvement in a niche not known for improvements.

The company had established an early lead over Merck’s $MRK Keytruda. But over the past few years Merck’s R&D group has been steadily making progress in the blockbuster rivalry, recently passing Bristol-Myers in quarterly revenue and putting itself on track to widen the gap. 

More recently Bristol-Myers has been looking to establish a niche for itself with cases involving a high tumor mutation burden, but they are facing some stiff headwinds on that quest.

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