UPDATED: Merck's Keytruda halves lung-cancer progression, death risk in big first-line victory

COPENHAGEN, Denmark--Back in June, Merck announced its immuno-oncology star Keytruda had pulled off a win in first-line non-small cell lung cancer, beating chemo at staving off disease progression and extending patients’ lives.

And Sunday at the ESMO 2016 Congress, the pharma giant revealed by just how much. The short version: It wasn’t close.

Keytruda (pembrolizumab) slashed 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 in the Keynote-024 trial, the drugmaker said. Median progression-free survival for patients on Keytruda came in at 10.3 months, versus 6 months for those on chemo.

The results “are really quite spectacular,” Roy Baynes, Merck SVP of global clinical development, told FiercePharma in an interview at ESMO. Thought leaders who have seen the data have described them as “transformational,” and Merck believes they’ll “be practice-changing for patients who meet these criteria,” he said.

It’s a big win for Merck, which is leap-frogging archrival Bristol-Myers Squibb--maker of Opdivo--in the NSCLC space. Currently, both meds boast second-line approvals, but use of Keytruda requires PD-L1 testing and Opdivo does not, which has held the Merck drug back. In August, though, Bristol announced that Opdivo had missed its mark in a first-line trial, failing to outperform chemo--and that news, coupled with Merck’s new data set, will make Keytruda the drug to beat going forward.

Plus, if physicians embrace PD-L1 testing in the front-line setting, Merck thinks they’ll embrace it in second-line, too, Baynes noted--and that could keep sales in the family.

“I think we are already seeing that physicians are embracing testing in the front-line setting,” he said. “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.”

Meanwhile, though, both drugmakers are scoping out first-line chemo combos, and Merck had some data to roll out on that front Sunday, too. In the Phase II Keynote-021 trial, Keytruda showed that, coupled with chemo, it could outperform chemo on its own, doubling the overall response rate and significantly improving progression free-survival regardless of patients’ PD-L1 status.

Of course, "response rate is not how oncology drugs are approved, nor is it how payers measure value," Bernstein analyst Tim Anderson wrote in a Sunday not to clients. But if ongoing Phase III trials confirm overall survival improvements, these data "suggest a future treatment paradigm in which chemo combo could be a preferred approach for PDL1(-) patients, and might be an option" for patients expressing PD-L1 levels of greater than 50%.

Merck, for one, believes that with those two datasets in mind, "frankly, pembrolizumab has a role to play in the vast majority of lung cancer patients in the front line and in second-line,” Baynes said. "Really, it covers the whole waterfront of lung cancer at this time.”

- read the release

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