Abstract

Pembro demonstrated promising ORR in sorafenib-treated patients (pts) with aHCC in KEYNOTE-224, leading to accelerated regulatory approval in the US. KEYNOTE-240 showed a similar ORR and clinically meaningful improvements in OS and PFS, although prespecified statistical significance criteria for OS and PFS were narrowly missed. KEYNOTE-394 demonstrated statistically significant and clinically meaningful benefit in OS, PFS, and ORR with pembro vs pbo in pts from Asia with sorafenib or oxaliplatin-based chemotherapy treated aHCC.

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