作者
T Yau, JW Park, RS Finn, A-L Cheng, P Mathurin, J Edeline, M Kudo, K-H Han, JJ Harding, P Merle, O Rosmorduc, L Wyrwicz, E Schott, SP Choo, RK Kelley, D Begic, G Chen, J Neely, J Anderson, B Sangro
发表日期
2019/10/1
期刊
Annals of Oncology
卷号
30
页码范围
v874-v875
出版商
Elsevier
简介
Background
SOR is approved as 1L therapy for pts with aHCC, but there is still an unmet need to prolong survival and improve tolerability. This phase III study compared clinical efficacy and safety of NIVO with SOR as 1L therapy in pts with aHCC.
Methods
Systemic therapy–naive pts aged ≥18 years with aHCC were randomized 1:1 to NIVO (240 mg IV Q2W) or SOR (400 mg oral BID). Primary endpoint was overall survival (OS). Additional endpoints were objective response rate (ORR) and progression-free survival (PFS) by blinded independent central review per RECIST v1.1, efficacy by tumor programmed death ligand 1 (PD-L1) expression, and safety.
Results
743 pts with aHCC were randomized to NIVO (n = 371) or SOR (n = 372) with minimum follow-up of 22.8 months at data cutoff. OS did not meet the predefined threshold of statistical significance (HR 0.84, P = 0.0419). Median OS (mOS) was 16.4 mo for NIVO …
学术搜索中的文章
T Yau, JW Park, RS Finn, AL Cheng, P Mathurin… - Annals of Oncology, 2019