Immuno-oncology, Results

Merck crushes Keynote-407 study in frontline lung cancer, hitting co-primaries and setting up another quick OK

Continuing its march to the total domination of frontline lung cancer treatment, Merck $MRK this morning announced that its Phase III Keynote-407 study hit both the overall survival as well as the progression-free survival goal posts they were aiming at.

Researchers tested a combination of Merck’s star PD-1 drug Keytruda in the frontline setting for metastatic squamous non-small cell lung cancer. They’re holding the numbers back for ASCO, but the news now adds fuel to Merck’s campaign to overtake Bristol-Myers Squibb as the number one PD-1/L1 manufacturer by sales revenue.

Roger Perlmutter

The news follows an unusual series of events for the pharma giant, which put out an early release at the beginning of May that the study had hit a key secondary endpoint, triggering a rush to file for an approval. In doing so, noted several analysts, Merck was slapping back conspiracy theorists who were spreading fears that the giant was sitting on bad data.

And in PD-1/L1 land, no one is sitting on anything good.

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 has pulled out all the stops.

At last count, Merck had 753 trials underway using Keytruda.

“As first-line treatment, KEYTRUDA in combination with traditional chemotherapy has now demonstrated an improved survival benefit, compared to chemotherapy alone, in metastatic lung cancer patients with squamous histology,” said Perlmutter, president, Merck Research Laboratories. “We look forward to presenting the overall survival and progression-free survival findings from KEYNOTE-407 at the 2018 ASCO Annual Meeting, and are grateful to the patients and investigators for their important contributions to this pivotal study.”


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