Immuno-oncology, Regulatory

FDA promises speedy review on moving Merck’s Keytruda up as first-line head and neck cancer therapy

Armed with crucial overall survival data in head and neck cancer, Merck is now steering Keytruda down the priority review speedway the FDA has just opened up for it.

An approval here — for the frontline use of Keytruda in head and neck cell carcinoma, both as a monotherapy and in combination with chemo — would follow an accelerated approval for recurrent or metastatic cases granted in 2016.

As Keytruda settles into its market-leading place, bolstered by a dominant position in frontline lung cancer, Merck has been busy pushing earlier uses of the PD-1 in other indications, including kidney cancer and esophageal carcinoma.

The pharma giant first staked a topline win for head and neck cancer last July, then followed up with numbers from the interim data analysis of KEYNOTE-048, which also serves as a confirmatory trial for the accelerated approval: In patients with high levels of PD-L1 (combined positive score ≥20), Keytruda improved OS by 39% compared to standard of care; in patients with lower levels, the improvement was 22%. When combined with chemo, the OS benefit registered at 23% regardless of PD-L1 expression.

They added:

[At this interim analysis] non-inferiority for Keytruda monotherapy in the total population was demonstrated and statistical significance was not achieved for the Keytruda combination in the subset of patients whose tumors expressed PD-L1 at CPS ≥20 or ≥1. Additionally, at this time point there was no difference in progression-free-survival (PFS), a dual primary endpoint of the study, in any of the groups studied.

The PDUFA date is now set for June 10. Given the FDA’s recent track record with oncology drugs, it’s likely that Merck will hear back before that.


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