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2017 ASCO Annual Meeting!

Session: Gastrointestinal (Noncolorectal) Cancer

Type: Oral Abstract Session

Time: Sunday June 4, 8:00 AM to 11:00 AM

Location: Hall D2

Phase III trial of lenvatinib (LEN) vs sorafenib (SOR) in first-line treatment of patients (pts) with unresectable hepatocellular carcinoma (uHCC).

Hepatobiliary Cancer

Gastrointestinal (Noncolorectal) Cancer

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr 4001)

Author(s): Ann-Lii Cheng, Richard S. Finn, Shukui Qin, Kwang-Hyub Han, Kenji Ikeda, Fabio Piscaglia, Ari David Baron, Joong-Won Park, Guohong Han, Jacek Jassem, Jean-Frédéric Blanc, Arndt Vogel, Dmitry Komov, T.R. Jeffry Evans, Carlos López-López, Corina E Dutcus, Min Ren, Silvija Kraljevic, Toshiyuki Tamai, Masatoshi Kudo; National Taiwan University Hospital, Taipei, Taiwan; David Geffen School of Medicine at University of California Los Angeles, Santa Monica, CA; Nanjing Bayi Hospital, Nanjing, China; Severance Hospital, Yonsei University, Seoul, South Korea; Toranomon Hospital, Tokyo, Japan; Azienda Ospedaliera Di Bologna, Bologna, Italy; California Pacific Medical Center Research Institute, San Francisco, CA; National Cancer Center Korea, Goyang-Si, South Korea; Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, China; Medical University of Gdańsk, Department of Oncology and Radiotherapy, Gdańsk, Poland; Service d’Hépato-Gastroentérologie et d’Oncologie Digestive, Groupe Hospitalier Saint André, Bordeaux, France; Hannover Medical School, Hannover, Germany; N. N. Blokhin Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Marqués de Valdecilla University Hospital, Santander, Spain; Eisai Co., Ltd., Woodcliff Lake, NJ; Eisai Co., Ltd., Hatfield, United Kingdom; Kindai University Faculty of Medicine, Osaka, Japan

Abstract Disclosures


Background: SOR is the only approved agent in uHCC and new options are needed. LEN, an inhibitor of vascular endothelial growth factor receptors 1‒3, fibroblast growth factor receptors 1‒4, platelet derived growth factor receptor α, RET, and KIT, showed activity in uHCC in a phase II trial. We report a phase III trial of LEN vs SOR as first-line therapy for uHCC. Methods: In this randomized, open-label, noninferiority (NI) study, pts had uHCC, ≥ 1 measurable target lesion, Barcelona Clinic Liver Cancer stage B or C, Child-Pugh class A, ECOG PS ≤ 1, and no prior systemic therapy. Pts were randomized 1:1 to LEN (body weight ≥ 60 kg: 12 mg/day; < 60 kg: 8 mg/day) or SOR 400 mg twice daily. The primary endpoint was overall survival (OS). The OS hazard ratio (HR) and its 95% CI were estimated with a stratified Cox proportional hazard model. The predefined NI margin was 1.08. Secondary efficacy endpoints were progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR) by modified RECIST. Type I error rates for secondary efficacy endpoints were controlled with a fixed sequence procedure at 2-sided α = 0.05 after OS NI was claimed. Results: 954 Pts enrolled (LEN: 478; SOR: 476). Efficacy outcomes are shown in the table. A similar number of pts in both arms had treatment-emergent adverse events (TEAEs). Most common LEN TEAEs were hypertension (42%), diarrhea (39%), decreased appetite (34%), decreased weight (31%), and fatigue (30%). Median (range) treatment duration was 5.7 mos (0−35.0) for LEN and 3.7 mos (0.1−38.7) for SOR. 13% Of LEN-treated and 9% of SOR-treated pts discontinued due to adverse events. 33% Of LEN-treated and 39% of SOR-treated pts received second-line therapy. Conclusions: LEN is noninferior in OS, and achieves statistically significant and clinically meaningful improvements in PFS, TTP, and ORR, as first line therapy for uHCC. TEAEs were consistent with the known LEN safety profile. Clinical trial information: NCT01761266

Median OS, mos (95% CI)13.6 (12.1−14.9)12.3 (10.4−13.9)0.92 (0.79−1.06)
Median PFS, mos (95% CI)*7.4 (6.9−8.8)3.7 (3.6−4.6)0.66 (0.57−0.77)
Median TTP, mos (95% CI)*8.9 (7.4−9.2)3.7 (3.6−5.4)0.63 (0.53−0.73)
ORR, n (%)*115 (24)44 (9)

*P< 0.00001

Other Abstracts in this Sub-Category:


1. Second-line tivantinib (ARQ 197) vs placebo in patients (Pts) with MET-high hepatocellular carcinoma (HCC): Results of the METIV-HCC phase III trial.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4000 First Author: Lorenza Rimassa
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


2. Phase III multi-centre open-label randomized controlled trial of selective internal radiation therapy (SIRT) versus sorafenib in locally advanced hepatocellular carcinoma: The SIRveNIB study.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4002 First Author: Pierce H. W. Chow
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer


3. Adjuvant capecitabine for biliary tract cancer: The BILCAP randomized study.

Meeting: 2017 ASCO Annual Meeting Abstract No: 4006 First Author: John Neil Primrose
Category: Gastrointestinal (Noncolorectal) Cancer - Hepatobiliary Cancer