Mer­ck touts a con­fir­ma­to­ry Keytru­da win for liv­er can­cer as 'dan­gling' ac­cel­er­at­ed ap­proval saga march­es on

Ac­cel­er­at­ed ap­proval for Mer­ck’s Keytru­da in a com­mon form of liv­er can­cer looked ten­u­ous af­ter a con­fir­ma­to­ry study whiffed on two sur­vival mea­sures. But af­ter ODAC rec­om­mend­ed to keep the drug on the mar­ket back in April, the phar­ma gi­ant said Mon­day an­oth­er tri­al has brought bet­ter tid­ings.

The block­buster PD-1 met its pri­ma­ry end­point in sta­tis­ti­cal­ly sig­nif­i­cant over­all sur­vival com­pared to place­bo, Mer­ck an­nounced Mon­day morn­ing, in a study eval­u­at­ing Keytru­da plus chemother­a­py in 453 he­pa­to­cel­lu­lar car­ci­no­ma pa­tients from Asia. Though Mer­ck didn’t re­port any spe­cif­ic fig­ures, the com­pa­ny not­ed Keytru­da al­so hit sec­ondary end­points for pro­gres­sion-free sur­vival and ob­jec­tive re­sponse rate.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER