Power Alley: Excellent FiercePharma Analysis Of FDA's Emerging Approval Calculus... And An Immaterial Merck Win, For Keytruda, In Cervical Cancers...

Well. . . when a patient has reached stage four, in cervical cancer, the oncologist is likely to try just about any combo -- experimentally -- if the patient consents, and most do. So this approval largely just codifies reimbursement from insurers for that already existing (and fairly smallish) patient population. Immaterial, to Merck -- so I didn't cover it yesterday.

What bears close reading, and further thinking, is FiercePharma's very fine reading / parsing of FDA's now steeping tea leaves, as to approvals -- generally.

That is, FDA increasing looks to see clear benefit in subgroups, before granting broad label approvals or expansions. By that light, Merck's Keynote-A18 study was. . . underwhelming. In time, the longer term data may support additional label expansion, to earlier stages of cervical cancer. . . but for now, the approval is smallish and narrow. Do read every word of this, at the link, if these matters are of more than passing interest to you, or your loved ones:

. . .Thanks to a new FDA nod, Merck’s Keytruda is the first PD-1 drug to be approved in combination with chemoradiotherapy to treat patients with stage 3 to 4a cervical cancer, the New Jersey pharma giant said Friday. This marks Keytruda’s 39th indication in the U.S.

The approval, however, was narrower than expected. It came on the back of results from the Keynote-A18 trial, which showed a tumor progression benefit for the Keytruda-chemoradiation regimen in a broader patient population with earlier-stage cervical cancer. . . .

Keynote-A18 tested the Keytruda combo in patients whose cancer was as early as stage 1b2. Among the entire trial population, adding Keytruda to chemoradiotherapy slashed the risk of progression or death by 30%.

But the progression-free survival benefit was markedly more pronounced in those with stage 3 to 4a disease, the approved FDA indication, where Keytruda’s addition was associated with a 41% improvement in the trial endpoint. In those with stage 1b2 to 2b disease, the benefit was just 9%, according to data presented at the European Society of Medical Oncology annual meeting in October. . . .

The imperfect nod for Keytruda tracks with an emerging trend from the FDA’s oncology department, which is increasingly looking for patient subgroups who didn’t benefit from large, inclusive trials. Drug companies often find that their strategy of asserting a statistically powered, overall trial win to seek a broad label—despite weak subgroup performances—no longer works with the FDA. . . .

Indeed. That is a piercing insight. Well done, by the dogged journalists at Fierce -- and onward.

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