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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

Pembrolizumab (pembro) in patients with advanced hepatocellular carcinoma (HCC): KEYNOTE-224 update.

Hepatobiliary Cancer

Gastrointestinal (Noncolorectal) Cancer

2018 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #209)

J Clin Oncol 36, 2018 (suppl; abstr 4020)

Author(s): Andrew X. Zhu, Richard S. Finn, Julien Edeline, Stéphane Cattan, Sadahisa Ogasawara, Daniel H. Palmer, Chris Verslype, Vittorina Zagonel, Laetitia Fartoux, Arndt Vogel, Debashis Sarker, Gontran Verset, Stephen Lam Chan, Jennifer J. Knox, Bruno Daniele, Scot Ebbinghaus, Junshui Ma, Abby B. Siegel, Ann-Lii Cheng, Masatoshi Kudo; Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA; University of California Los Angeles, Los Angeles, CA; Centre Eugene Marquis, Rennes, France; CHRU de Lille Hopital Claude Huriez, Lille, France; Chiba University Graduate School of Medicine, Chiba, Japan; University of Liverpool, Liverpool, United Kingdom; University Hospitals Leuven, Leuven, Belgium; Istituto Oncologico Veneto IOV-IRCCS, Padova, Italy; Hopital de la Pitie Salpetriere, Paris, FR; Medizinische Hochschule Hannover, Hannover, Germany; King's College Hospital, Institute of Liver Studies, London, United Kingdom; Erasme Hospital, Brussels, Belgium; Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong; Princess Margaret Cancer Centre and University of Toronto, Toronto, ON, Canada; G.Rummo Hospital, Benevento, Italy; Merck & Co., Inc., Kenilworth, NJ; National Taiwan University Hospital, Taipei, Taiwan; Kindai University Faculty of Medicine, Osaka, Japan

Abstract Disclosures


Background: Initial results from KEYNOTE-224 (NCT02702414), an open label, phase 2 trial showed that pembro, an anti-PD-1 antibody, was active and safe in pts with advanced HCC previously treated with sorafenib. Here we report updated clinical results and biomarker studies. Methods: Eligible pts were age ≥18 y with histologically confirmed HCC, radiographic progression on/intolerance to sorafenib and disease not amenable to curative treatment, Child Pugh A, ECOG PS 0-1 and BCLC stage C or B. Pts received pembro 200 mg IV Q3W for 2 y or until disease progression, unacceptable toxicity, withdrawal of consent or investigator decision. Response was assessed every 9 wk. Primary endpoint was ORR (RECIST v1.1, central review). Secondary endpoints were DOR, DCR, PFS, OS and safety. Exploratory endpoint was relationship of PD-L1 IHC combined positive and tumor proportion scores (CPS and TPS; n = 52), and T cell inflamed gene expression profile (GEP; n = 42) with response. Data cutoff date was Nov 24, 2017. Results: Of 104 treated pts, 18 remained on therapy. Median age was 68 y (range 43-87), 21.2% were HBV+, 26% were HCV+, 94.2% were Child Pugh A, 79.8% had PD on sorafenib and 64.4% had extrahepatic disease. ORR was 16.3% (95% CI, 9.8 to 24.9, n = 17) and similar across differing etiologies; 66% of responders had duration ≥12 mo (Kaplan Meier) and median response duration was not reached (3.1 - 12.5+ mo). Best response was CR in 1 pt (1.0%), PR in 16 (15.4%), SD in 47 (45.2%) and PD in 34 (32.7%); DCR was 61.5%. Median PFS (95% CI) was 4.9 mo (3.4 to 7.0) and OS was 12.9 mo (9.7 to NA). PFS and OS 12 mo rates were 25.4% and 53.6%, respectively. Safety was similar to that observed for pembrolizumab in other indications. Immune-mediated hepatitis occurred in 3 (2.9%) pts; no cases of HBV/HCV flare were seen. Higher PD-L1 CPS in tumor and immune cells was associated with higher ORR and longer PFS, while PD-L1 TPS in tumor cells alone and GEP showed less robust associations with outcomes. Conclusions: These results confirm that pembro may be a promising treatment option for pts with advanced HCC. PD-L1 CPS was associated with clinical response to pembro while results for PD-L1 TPS and GEP were less robust; further study is needed to better define these relationships. Clinical trial information: NCT02702414

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