FDA slams Incyte's PD-1 over single-arm study, low response and trial deaths
The ever-growing PD-1 landscape could see a new entrant as an Incyte program is slated for an FDA decision next month. But first, the biotech will have to get through an adcomm Thursday, and briefing documents from the agency appear to cast doubt over how effective the candidate really is.
Atop the issues is whether or not the compound retifanlimab has enough data for an accelerated approval, after Incyte treated second-line patients with squamous carcinoma of the anal canal in a single-arm trial. Incyte’s study showed an overall response rate of just 14% among 94 patients, and the FDA says they’re unsure whether this would correspond to a clinical benefit in a larger, placebo-controlled trial.
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