That didn’t take long.
Just a couple of weeks after presenting full results of its first-line lung cancer monotherapy study for immuno-oncology star Keytruda, Merck has snagged a coveted FDA nod in the indication.
Regulators have green-lighted Keytruda as a treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations. And with that go-ahead, the company has cemented its rise “from laggard to leader” in the space, as Bernstein analyst Tim Anderson put it in a note to clients.
The approval--which comes about two months earlier than the expected FDA decision date of Dec. 24--comes based on data from Merck’s Keynote-024 study, which showed that Keytruda cut the risk of disease progression or death by 50% and the risk of death by 40% among patients expressing PD-L1 levels of 50% or greater. Median progression-free survival for patients on Keytruda registered at 10.3 months, compared with 6 months for those on chemo.
Those results--paired with a surprise recent front-line miss from Bristol-Myers Squibb’s Opdivo, which analysts expected to emerge victorious in the NSCLC market-share battle--put Merck ahead of the pack. The front-line setting includes a larger patient pool that tends to stay on therapy for longer, and with the head start there, Merck “now grows ahead of the group average,” Anderson predicted.
But the first-line thumbs up wasn’t the only good Keytruda news Merck got on Monday. The FDA also approved a label update for the med that included favorable data from the second-line setting, where Keytruda was running behind Opdivo thanks to a limited nod requiring PD-L1 testing.
The way Anderson sees it, “the label change should segue into a clear, fast trajectory change in Keytruda's uptake,” he wrote. And that’s great timing for Keytruda to receive a boost, considering Roche’s third-to-the-party Tecentriq won its own second-line NSCLC nod last week.
Plus, Merck’s new front-line edge could help balance out the second-line testing setback. Now that Keytruda has its first-line indication--which also requires patients to undergo PD-L1 testing before receiving treatment--Merck predicts that physicians will embrace the testing. And the pharma giant is hoping that openness from docs will extend to the second-line setting, too.
“I think we are already seeing that physicians are embracing testing in the front-line setting,” Roy Baynes, Merck SVP of global clinical development, told FiercePharma in an interview at ESMO. “Testing is not anything unusual for lung cancer patients; the vast majority of lung caner patients are tested for EGFR mutations and ALK mutations, and this will be another test that gets done.”
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