Results

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
Endpoints News


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.


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 34,900+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Biotech Investment Analyst
SV Health Investors Boston, MA
Research Scientist - Disease Biology
Recursion Pharmaceuticals Salt Lake City, UT
Senior Scientist - Predictive Pharmacology
Recursion Pharmaceuticals Salt Lake City, UT
Director, Translational Sciences
Cadent Therapeutics Cambridge, MA
Director of Marketing
twoXAR Mountain View, CA

Visit Endpoints Careers ->