ESMO: Merck's Keytruda doubles 5-year survival rate for lung cancer patients

Merck's Keytruda was the first immuno-oncology drug approved in first-line NSCLC. (Merck)

Immuno-oncology competition has mounted this year in previously untreated, metastatic non-small cell lung cancer. But Merck’s Keytruda, the first PD-1/PD-L1 on the market in the setting, has new long-term survival results that the drugmaker hopes will help bolster its position.

Keytruda doubled the five-year survival rate for patients whose tumors expressed levels of biomarker PD-L1 above 50%, with 31% of patients phase 3 study patients reaching that mark compared with just 16% of those who underwent chemo.

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Keytruda monotherapy also clocked a median response lasting 29.1 months, nearly five times longer than chemo’s 6.3 months, according results presented Monday at the European Society for Medical Oncology’s virtual annual meeting.

“I think it’s tremendously encouraging for patients that are facing a lung cancer diagnosis to be able to think about living for five years or longer from the time they’re diagnosed,” Scot Ebbinghaus, Merck VP of clinical research, said.

Before Keytruda hit the scene, the five-year survival mark in this patient group “was in the ballpark of 5%,” he noted.

And there was another feature of the data set Ebbinghaus pointed to as “remarkable.”

“If you look at the percentage of patients who actually finished two years of therapy with Keytruda … 80% of those patients were alive at five years, and about half of those patients had not required any subsequent therapies,” he said.

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The data come from Merck’s Keynote-024 trial, which nabbed Keytruda a solo nod in first-line NSCLC just a couple weeks after the New Jersey drugmaker presented results at ESMO’s 2016 confab.

That green light—coupled with a big miss for Bristol Myers Squibb’s Opdivo and a major Keytruda-chemo combo approval in 2017—cemented Keytruda as the player to beat in the front-line lung cancer arena, considered immuno-oncology’s largest market.

Lately, though, Merck has seen an influx of competition from Bristol, which nabbed a pair of Opdivo combo approvals this past May—including one for a chemo-free Opdivo-Yervoy regimen in all PD-L1-positive patients, not just those whose tumors bear high levels of the protein.

None of Keytruda’s competitors, though, can show the kind of long-term data that Merck can, Ebbinghaus pointed out.

“I think these data show that even with all the emerging new data with combinations coming out, that patients can have an option which is not chemo” that’s “generally tolerable” and provides “a substantial long-term benefit,” he said.