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Attend this session at the
2019 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Discussion Session

Time: Monday June 3, 3:00 PM to 4:30 PM

Location: Arie Crown Theater

Nivolumab (NIVO) + ipilimumab (IPI) combination therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC): Results from CheckMate 040.

Hepatobiliary Cancer

Gastrointestinal (Noncolorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #117)

J Clin Oncol 37, 2019 (suppl; abstr 4012)

Author(s): Thomas Yau, Yoon-Koo Kang, Tae-You Kim, Anthony B. El-Khoueiry, Armando Santoro, Bruno Sangro, Ignacio Melero, Masatoshi Kudo, Ming-Mo Hou, Ana Matilla, Francesco Tovoli, Jennifer J. Knox, Aiwu Ruth He, Bassel F. El-Rayes, Mirelis Acosta-Rivera, Jaclyn Neely, Yun Shen, Carlos Baccan, Christine Marie Dela Cruz, Chiun Hsu; The University at Hong Kong, Hong Kong, China; Asan Medical Center, University of Ulsan, Seoul, South Korea; Seoul National University, Seoul, South Korea; USC Norris Comprehensive Cancer Center, Los Angeles, CA; Istituto Clinico Humanitas, Rozzano, Italy; Clinica Universidad de Navarra and CIBEREHD, Pamplona, Spain; Universidad de Navarra, Pamplona, Spain; Kindai University Faculty of Medicine, Osaka, Japan; Chang Gung Memorial Hospital, Taipei, Taiwan; Servicio de Digestivo, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Department of Medical & Surgical Sciences, University of Bologna, Bologna, Italy; Princess Margaret Cancer Centre, Toronto, ON, Canada; Georgetown University Hospital, Washington DC, DC; Emory University Winship Center, Atlanata, GA; Fundación de Investigación, San Juan, PR; Bristol-Myers Squibb, Princeton, NJ; National Taiwan University Hospital, Taipei, Taiwan

Abstract Disclosures


Background: NIVO monotherapy (mono) is approved for sorafenib (SOR)-treated pts with HCC based on data from CheckMate 040 (NCT01658878), which reported an objective response rate (ORR) of 14% and median overall survival (mOS) of 16 months (mo). This is the first report of efficacy and safety of the NIVO + IPI combination in SOR-treated pts with aHCC. Methods: Pts were randomized to 3 arms: [A] NIVO 1 mg/kg + IPI 3 mg/kg Q3W (4 doses) or [B] NIVO 3 mg/kg + IPI 1 mg/kg Q3W (4 doses), each followed by NIVO 240 mg Q2W, or [C] NIVO 3 mg/kg Q2W + IPI 1 mg/kg Q6W. Treatment continued until intolerable toxicity or disease progression. Primary endpoints included safety and tolerability. Secondary endpoints included ORR (BICR per RECIST v1.1), duration of response (DOR), disease control rate (DCR), and OS. Cutoff was 25 Sep 2018. Results: 148 SOR-treated pts were randomized. Minimum follow-up for OS from last pt randomization date to data cutoff was 24 mo. At baseline: 88% had vascular invasion or extrahepatic spread, 91% had BCLC stage C, 84% discontinued SOR due to disease progression and 14% due to toxicity. Overall, ORR was 31% (7 had a complete response [CR]) with a median DOR of 17 mo; DCR was 49% and 24-mo OS rate was 40%. Pts in arm A had a mOS of 23 mo and 4 pts had a CR. The table shows additional efficacy results by arm. Overall, NIVO + IPI was well tolerated; 37% of pts had a grade 3–4 treatment-related adverse event (TRAE; most common: pruritus and rash); 5% had grade 3–4 TRAEs leading to discontinuation. Conclusions: NIVO + IPI led to clinically meaningful responses and had an acceptable safety profile in SOR-treated pts, with an ORR twice that of NIVO mono (31% and 14%, respectively). Pts in arm A had the most promising mOS of 23 mo. Clinical trial information: NCT01658878

Q3W (n = 50)
Q3W (n = 49)
Q6W (n = 49)
ORR, n (%)16 (32)15 (31)15 (31)
Complete response4 (8)3 (6)0
Partial response12 (24)12 (24)15 (31)
Stable disease9 (18)5 (10)9 (18)
Progressive disease20 (40)24 (49)21 (43)
DCR, % (95% CI)54 (39–68)43 (29–58)49 (34–64)
mOS, mo (95% CI)23 (9–NA)12 (8–15)13 (7–33)
12-mo OS rate, % (95% CI)61 (46–73)56 (41–69)51 (36–64)
24-mo OS rate, % (95% CI)48 (34–61)30 (18–44)42 (28–56)

NA, not available.

Other Abstracts in this Sub-Category:


1. A multicenter randomized controlled trial to evaluate the efficacy of surgery vs. radiofrequency ablation for small hepatocellular carcinoma (SURF trial).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4002 First Author: Namiki Izumi
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


2. ABC-06 | A randomised phase III, multi-centre, open-label study of Active Symptom Control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy.

Meeting: 2019 ASCO Annual Meeting Abstract No: 4003 First Author: Angela Lamarca
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


3. First-line avelumab + axitinib in patients with advanced hepatocellular carcinoma: Results from a phase 1b trial (VEGF Liver 100).

Meeting: 2019 ASCO Annual Meeting Abstract No: 4072 First Author: Masatoshi Kudo
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer