Results

Merck claims a needed win for Keytruda with interim OS data in head and neck cancer

Merck has stocked up on data to support moving Keytruda up as a first-line therapy for head and neck squamous cell carcinoma.

An interim analysis of the Keynote-048 study suggested that the checkpoint inhibitor significantly improved overall survival — one of two primary endpoints — in patients whose tumors expressed PD-L1. The dual-primary endpoint of progression-free survival, however, has not been reached.

In the 825-patient trial, researchers found the most encouraging results when comparing a Keytruda monotherapy regime against the current standard of care: a combo of cetuximab (Erbitux), platinum chemotherapy (cisplatin or carboplatin) and 5-Fluorouracil (Adrucil).

A third group of patients received Keytruda in combination with platinum chemotherapy plus 5-Fluorouracil — though there was no word yet on how they did.

It’s been about two years since Merck won an accelerated approval to use the drug in second-line cases head and neck squamous cell carcinoma in combination with platinum-containing chemo. While the drug narrowly flunked an earlier trial comparing the PD-1 checkpoint star to standard therapies in that indication, the FDA took no action and Keynote-048 was considered by Leerink analyst Seamus Fernandez to be “another shot on goal for full approval in H&N cancer, as the Keynote-048 study in first-line patients could, if positive, serve as the confirmatory trial.”

We will have to wait to see if it comes through for Merck, which is marching on with the trial while presenting the interim data at an upcoming medical meeting and submitting them to regulators around the world.

The final results will also have a bearing on the whole checkpoint field, where experts have struggled to explain differing outcomes among PD-1s that were previously thought to have the same clinical profile. Whereas Keytruda has succeeded in areas Bristol-Myers’ Squibb’s Opdivo has failed, the tables were turned in head and neck cancer — with Bristol-Myers posting positive Phase III data back in 2016.


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