CHICAGO — After getting snubbed at AACR in its showdown with Merck over frontline lung cancer, Bristol-Myers Squibb is back at ASCO with updated data on its checkpoint star Opdivo in combination with chemo as well as a low dose of the CTLA-4 drug Yervoy. And it’s likely to still face an uphill climb against the skeptics.
That checkpoint plus chemo combo — where Merck has been reigning supreme — came in with a hazard ratio of 0.74 among patients with less than 1% PD-L1 expression. And the Opdivo/Yervoy combo did better on progression-free survival at this stage of the 1b portion of CheckMate-227 when patients are winnowed down by the size of their tumor mutation burden.
Using its own definition for high tumor mutation burden, researchers found that 45% of the Opdivo/Yervoy group achieved a one-year cutoff for progression-free survival, followed by 27% for the chemo combo and 8% with chemo. Patients who fell below the TMB cutoff did much worse, with 18% and 16% one-year PFS rates.
“Results show Opdivo plus chemotherapy improved progression-free survival versus chemotherapy in first-line lung cancer patients whose tumors do not express PD-L1,” said study investigator Hossein Borghaei in a statement. “Taken together with the totality of CheckMate – 227 data presented to date, the results reinforce that TMB status provides clinically relevant information for Opdivo-based combinations and that Opdivo plus low-dose Yervoy provided durable efficacy in patients with high TMB.”
Analysts, though, have continued to cheer on Merck’s rival Keytruda effort, preferring the checkpoint/chemo combo that now dominates the treatment of frontline cancer. The idea of adding a test on TMB, accepting it as a new qualifier for patients, isn’t sitting well with the key opinion leaders on the investment front. And there’s been considerable grumbling over the way that Bristol-Myers has redesigned ‘227, even though this time the data continues to fall into the promising category.
Bristol-Myers gained an early edge in the competition with Merck. But Merck’s research team under Roger Perlmutter gets top marks for avoiding the missteps that tripped up Bristol-Myers on lung cancer, a huge market for this category of drug.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 30,000+ biopharma pros who read Endpoints News by email every day.Free Subscription