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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