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.
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