Merkel cell provides Incyte’s laggard a way in

A few years ago the first approval of an anti-PD-(L)1 drug would have been trumpeted far and wide. But with seven already on the US market Incyte did not even disclose that it had filed the Macrogenics-originated retifanlimab, and the announcement yesterday that the drug had been approved as Zynyz for Merkel cell carcinoma thus came as a surprise. Investors received it with a shrug, presumably because Merkel cell is such an insignificant use. Still, this is not the point; Incyte needed retifanlimab to be approved not so it could have a monotherapy challenger but to give it an in-house PD-1 backbone for future combinations. The key lesson for laggards pursuing similar strategies is that Merkel cell – where only Merck & Co’s Keytruda and Merck KGaA/Pfizer’s Bavencio are approved, both through the accelerated pathway – remains a viable niche indication in which a quick nod is possible. Incyte had tried and failed to get retifanlimab greenlit in another peripheral use, squamous cell carcinoma of the anal canal, but a US adcom slammed its data in 2021, and a complete response letter followed.