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Attend this session at the
2018 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Session

Time: Sunday June 3, 8:00 AM to 11:30 AM

Location: Hall A

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Poster Discussion Session

Time: Sunday June 3, 4:45 PM to 6:00 PM

Location: Hall D2

Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: Results from the randomized phase 3 CELESTIAL trial.

Hepatobiliary Cancer

Gastrointestinal (Noncolorectal) Cancer

2018 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #208)

J Clin Oncol 36, 2018 (suppl; abstr 4019)

Author(s): Ghassan K. Abou-Alfa, Tim Meyer, Ann-Lii Cheng, Anthony El-Khoueiry, Lorenza Rimassa, Baek-Yeol Ryoo, Irfan Cicin, Philippe Merle, Yen-Hsun Chen, Joong-Won Park, Jean-Frédéric Blanc, Luigi Bolondi, Heinz Josef Klümpen, Stephen Lam Chan, Vincenzo Dadduzio, Colin Hessel, Anne E. Borgman-Hagey, Gisela Schwab, Robin Kate Kelley; Memorial Sloan Kettering Cancer Center, New York, NY; University College London Cancer Institute, London, United Kingdom; National Taiwan University Hospital, Taipei, Taiwan; USC Norris Comprehensive Cancer Center, Los Angeles, CA; Humanitas Clinical and Research Center, Rozzano, Italy; Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South); Department of Medical Oncology, Trakya University Faculty of Medicine, Edirne, Turkey; INSERM U1052, Lyon, France; Chi-Mei Liouying Hospital, Tainan, Taiwan; National Cancer Center Korea, Goyang-Si, Korea, Republic of (South); Service d’Hépato-Gastroentérologie et d’Oncologie Digestive, Groupe Hospitalier Saint André, Bordeaux, France; Department of Medical and Surgical Sciences, University of Bologna and Center for Applied Biomedical Research (CRBA), S.Orsola-Malpighi Hospital, Bologna, Italy; Department of Clinical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands; Department of Clinical Oncology, State Key Laboratory of Oncology in South China, The Chinese University of Hong Kong, Hong Kong, Hong Kong; Universitat Oberta de Catalunya/ Istituto Oncologico Veneto, IRCCS, Padova, Italy; Exelixis, Inc., South San Francisco, CA; University of California San Francisco, San Francisco, CA

Abstract Disclosures


Background: C, an inhibitor of MET, VEGFR, and AXL, has previously shown clinical activity in pts with advanced HCC. This phase 3 trial (NCT01908426) evaluated C vs P in previously treated pts with advanced HCC. Methods: In this double-blind, global, phase 3 trial, pts were randomized 2:1 to C (60 mg qd) or matched P stratified by etiology, geographic region, and presence of extrahepatic spread and/or macrovascular invasion (EHS/MVI). Eligible pts had pathologic diagnosis of HCC, Child-Pugh score A, and ECOG PS ≤1. Pts must have received prior sorafenib, were allowed to receive up to 2 lines of prior systemic therapy for HCC, and must have progressed following at least one. The primary endpoint was overall survival (OS). Secondary endpoints were investigator-assessed progression-free survival (PFS) and objective response rate (ORR) per RECIST 1.1. The study was designed to detect a hazard ratio (HR) for OS of 0.76 (90% power, 2-sided α = 0.05) at the final analysis with 2 prespecified interim analyses at 50% and 75% of the planned 621 events. Results: As of 1 Jun 2017, 707 pts were randomized, and 484 deaths had occurred (317 out of 470 for C; 167 out of 237 for P). Baseline characteristics were balanced between the arms: median age was 64 years, 82% were male, 38% had HBV, 24% had HCV, 25% enrolled in Asia, 85% had EHS/MVI, and 27% had received 2 prior systemic regimens for advanced HCC. The study met the primary endpoint at the second planned interim analysis with median OS 10.2 mo for C vs 8.0 mo for P (HR 0.76, 95% CI 0.63–0.92; p = 0.0049). Median PFS was 5.2 mo for C vs 1.9 mo for P (HR 0.44, 95% CI 0.36–0.52; p < 0.0001), and ORR was 4% vs 0.4% (p = 0.0086). The most common grade 3/4 adverse events (predominantly grade 3) with higher incidence in the C vs P arm included hand-foot skin reaction (17% vs 0%), hypertension (16% vs 2%), increased aspartate aminotransferase (12% vs 7%), fatigue (10% vs 4%), and diarrhea (10% vs 2%). Subgroup analyses of OS and PFS by baseline characteristics will also be presented. Conclusions: C significantly improved OS and PFS vs P in previously treated pts with advanced HCC. Adverse events were consistent with the known safety profile of C. Clinical trial information: NCT01908426

Other Abstracts in this Sub-Category:


1. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib.

Meeting: 2018 ASCO Annual Meeting Abstract No: 4003 First Author: Andrew X. Zhu
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


2. Randomized phase III study of gemcitabine plus S-1 combination therapy versus gemcitabine plus cisplatin combination therapy in advanced biliary tract cancer: A Japan Clinical Oncology Group study (JCOG1113, FUGA-BT).

Meeting: 2018 ASCO Annual Meeting Abstract No: 4014 First Author: Makoto Ueno
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


3. Randomized, open label, multicenter, phase II trial of transcatheter arterial chemoembolization (TACE) therapy in combination with sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.

Meeting: 2018 ASCO Annual Meeting Abstract No: 4017 First Author: Masatoshi Kudo
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer