Josep M Llovet, Masatoshi Kudo, Philippe Merle, Tim Meyer, Shukui Qin, Masafumi Ikeda, Ruocai Xu, Julien Edeline, Baek-Yeol Ryoo, Zhenggang Ren, Gianluca Masi, Mariusz Kwiatkowski, Ho Yeong Lim, Jee Hyun Kim, Valeriy Breder, Hiromitsu Kumada, Ann-Lii Cheng, Peter R Galle, Shuichi Kaneko, Anran Wang, Kalgi Mody, Corina Dutcus, Leonid Dubrovsky, Abby B Siegel, Richard S Finn
BACKGROUND: Systemic therapies have improved the management of hepatocellular carcinoma, but there is still a need to further enhance overall survival in first-line advanced stages. This study aimed to evaluate the addition of pembrolizumab to lenvatinib versus lenvatinib plus placebo in the first-line setting for unresectable hepatocellular carcinoma. METHODS: In this global, randomised, double-blind, phase 3 study (LEAP-002), patients aged 18 years or older with unresectable hepatocellular carcinoma, Child Pugh class A liver disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no previous systemic treatment were enrolled at 172 global sites...
December 2023: Lancet Oncology