Merck & Co. may have yet another lung cancer score coming for Keytruda. The pharma giant is submitting data from a Keytruda-plus-chemo combo trial to the National Comprehensive Cancer Network, looking for backing in an influential compendia of treatment guidelines.
Though the bid for a compendium listing is based on a Phase II study, that trial won laurels at the recent European Society for Clinical Oncology meeting--and raised hopes that Keytruda would have even more utility in first-line lung cancer than expected.
That study tested Keytruda, a PD-1 immunotherapy, alongside Eli Lilly’s Alimta and the generic chemo drug carboplatin, compared with the Alimta-chemo combo alone. The Keytruda group showed a 55% response rate, compared with 29% for the standard duo, and patients in the Keytruda arm lived for 13 months without their disease progressing, compared with 8.9 months in the control arm.
The “strongly positive” results from this study, Keynote-021, “surprised investors,” Bernstein analyst Tim Anderson said in a note last week. And now, Merck has submitted that data to the NCCN, looking for its blessing. Payers typically cover NCCN-listed uses for cancer drugs, even if they’re not specifically approved by the FDA, and this would allow doctors to go ahead and prescribe the regimen.
Anderson gives the Keytruda combo about a 25% chance of winning the network’s backing, and even then expects it to carry a “2b” rating, which reflects a lower level of evidence than a Phase III trial would provide.
But if NCCN comes through, the listing “would open up a new revenue opportunity ... for Keytruda” sooner than market-watchers had expected. And it could add to the “halo effect” for Merck in lung cancer, given that it’s following up on Keytruda’s monotherapy win in first-line NSCLC, whose details were also unveiled at ESMO.
Actually, it could add to Keytruda’s halo effect, period, giving the drug “an uplift even in other non-lung cancer tumor types,” Anderson notes.
Oncologists surveyed by Bernstein showed “broad support” for the Keytruda-chemo combo approach, and they said they’d consider it competitive with another combination type--PD-1 plus CTLA-4, now typified by Bristol-Myers Squibb’s Opdivo/Yervoy regimen--that’s under testing in a variety of combos from a variety of pharma players.
Of course, it’s the Keytruda monotherapy data that’s drawn the most attention in first-line NSCLC, what with Bristol-Myers’ Opdivo failing to beat chemo in the same setting (though the trials were designed quite differently). At ESMO, Merck SVP of global clinical development Roy Baynes told FiercePharma that leaders who’d seen the monotherapy data have described them as “transformational,” and Merck believes they’ll “be practice-changing for patients who meet these criteria,” he said.
But with the monotherapy and Keytruda-chemo datasets both 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.”
Meanwhile, Roche just nabbed a second-line lung cancer nod for its third-to-market immunotherapy Tecentriq. The FDA awarded it a broad label--to treat patients regardless of their PD-L1 biomarker status--which analysts see as a major bonus as it jockeys for market share.
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