Checkmate-040: Nivolumab (NIVO) in patients (pts) with advanced hepatocellular carcinoma (aHCC) and Child-Pugh B (CPB) status.

作者：Masatoshi Kudo, Ana Matilla, Armando Santoro, Ignacio Melero, Antonio Cubillo Gracián, Mirelis Acosta-Rivera, Su Pin Choo, Anthony B. El-Khoueiry, Ryoko Kuromatsu, Bassel F. El‐Rayes, Kazushi Numata, Yoshito Itoh, Francesco Di Costanzo, Oxana Crysler, María Reig, Yun Shen, Jaclyn Neely, Christine Marie Dela Cruz, Carlos Baccan, Bruno Sangro · 发表于：Journal of Clinical Oncology · 年份：2019 · DOI：10.1200/jco.2019.37.4_suppl.327 · 被引用次数：99 · 研究领域：Cancer Immunotherapy and Biomarkers、Bladder and Urothelial Cancer Treatments、Colorectal Cancer Treatments and Studies

327 Background: Pts with aHCC and CPB liver status are often excluded from clinical trials of novel therapies due to their poor prognosis (Greten British J Cancer 2005). Historical overall survival (OS) for these pts when treated with sorafenib (SOR) has ranged ≈3–5 mo in retrospective or descriptive studies (Abou-Alfa Gastrointest Cancer Res 2011; Da Fonseca Mol Clin Oncol 2015; Pressiani Ann Oncol 2013; Chiu Cancer 2012); thus, novel treatment options are needed for these pts. The PD-1 inhibitor NIVO is approved in the US, Canada, and elsewhere, most recently Australia, for SOR-treated pts with aHCC based on results from CheckMate-040 (NCT01658878) (El-Khoueiry Lancet 2017). Here we report data from the CPB cohort of CheckMate-040, the first prospective study of immunotherapy in this pt group. Methods: Pts with CPB (B7–B8) aHCC who were SOR-naïve (n = 25) or -experienced (n = 24) received NIVO 240 mg IV for 30 min Q2W until unacceptable toxicity or disease progression. Primary endpoints were objective response rate (ORR) (investigator assessed [INV], RECIST v1.1) and duration of response (DOR). Safety was assessed in all treated pts using NCI CTCAE v4.0. Results: Of 49 analyzed pts, 28 (57.1%) had vascular invasion or extrahepatic spread. During a follow-up range of 6–18 mo, INV ORR was 10.2% with 5 pts responding; disease control rate (DCR) was 55.1%. Median (m) time to response was 2.7 mo and mDOR was 9.9 mo; 2 pts had ongoing responses at data cutoff. The mOS was 7.6 mo ...