Merck has caught the big wave on frontline lung cancer, and it plans to ride an early positive signal straight through to a quick OK for another lucrative market niche for Keytruda.
This morning the pharma giant posted word that their Keynote-407 trial scored a positive hit on the overall response rate for untreated metastatic squamous non-small cell lung cancer in an interim analysis and they’ve already filed for the approval.
That’s a secondary endpoint and just a cohort of patients, but Merck isn’t waiting to find out the rest of the data. They want a green light to start marketing ASAP using just a piece of the puzzle. And at this stage, with regulators speeding approvals in cancer, there’s good reason to believe that the FDA will give it to them.
Researchers are also busily gathering the rest of the data on primary endpoints for overall survival and progression-free survival. Merck adds that it plans for a late-breaking session at ASCO to unveil more on this study.
Merck shares $MRK are up 2% in pre-market trading.
In the latest quarterly matchup between Merck and its big rival Bristol-Myers Squibb, Merck had inched up to within punching distance of pushing past Bristol-Myers on PD-1 revenue. Bristol-Myers pushed out well ahead of Merck early in this intense rivalry, but Roger Perlmutter’s R&D crew have pulled out all the stops.
At last count, Merck had 753 trials underway using Keytruda.
Merck won their latest bout in the heavyweight rivalry at AACR with the details on their frontline win for the Keytruda-chemo combo for lung cancer. Bristol-Myers tried hard to show that it had the edge in a large group of patients with a high tumor mutation burden, but analysts overall were much more impressed by Merck’s domination in a more classically defined patient group.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 37,700+ biopharma pros who read Endpoints News by email every day.Free Subscription