Robert Davis, Merck CEO

Al­most three years af­ter whiff­ing in a con­fir­ma­to­ry study, Mer­ck touts new da­ta for Keytru­da in HCC

Keytru­da’s ac­cel­er­at­ed ap­proval in a com­mon form of liv­er can­cer looked shaky af­ter the drug failed on two sur­vival mea­sures in a con­fir­ma­to­ry study al­most three years ago. Now Mer­ck’s tout­ing what could be a con­fir­ma­to­ry win — but will three pa­tient deaths mar its chances?

A reg­i­men of Keytru­da plus best sup­port­ive care re­duced pa­tients’ risk of death by 21% com­pared to place­bo plus sup­port­ive care (p=0.0180), meet­ing the pri­ma­ry end­point in the Phase III KEYNOTE-394 study, Mer­ck an­nounced on Tues­day. The tri­al en­rolled 453 Asian pa­tients with ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma (HCC), who had pre­vi­ous­ly been treat­ed with so­rafenib or ox­ali­platin-based chemother­a­py.

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