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Poster display session

2332 - KEYNOTE-240: Phase 3, randomized study of pembrolizumab (pembro) vs best supportive care (BSC) for second-line advanced hepatocellular carcinoma (HCC)

Date

09 Sep 2017

Session

Poster display session

Presenters

Richard Finn

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

R.S. Finn1, S.L. Chan2, A.X. Zhu3, J. Knox4, A. Cheng5, A.B. Siegel6, O. Bautista7, M. Kudo8

Author affiliations

  • 1 Medical Oncology, University of California, Los Angeles, 90095 - Los Angeles/US
  • 2 Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin/HK
  • 3 Oncology, Massachusetts General Hospital, 02114 - Boston/US
  • 4 Oncology, Princess Margaret Cancer Centre and University of Toronto, Toronto/CA
  • 5 Oncology, National Taiwan University Hospital, 100 - Taipei/TW
  • 6 Oncology, Merck & Co., Inc., 07033 - Kenilworth/US
  • 7 Oncology, Merck & Co., Inc., Kenilworth/US
  • 8 Oncology, Kindai University Faculty of Medicine, Osaka/JP
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Resources

Abstract 2332

Background

Sorafenib is the standard of care (SOC) for first-line HCC; however, there is no clear SOC after disease progression on or intolerance to sorafenib. Because most HCC is driven by inflammation, the rationale to evaluate immunotherapy in patients (pts) with this type of cancer is strong. The randomized, double-blind, placebo-controlled phase 3 KEYNOTE-240 study (ClinicalTrials.gov, NCT02702401) was designed to compare efficacy and safety of the anti–PD-1 antibody pembro + BSC vs placebo + BSC in pts with previously treated advanced HCC.

Trial design

Pts aged ≥18 years with histologically or cytologically confirmed HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes excluded), documented progression after stopping treatment with sorafenib or intolerance to sorafenib, no previous systemic therapy for HCC other than sorafenib, disease not amenable to a curative treatment approach (eg, transplantation, surgery, or ablation), measurable disease confirmed by central imaging vendor review per RECIST v1.1, Child-Pugh liver score A, ECOG performance status 0-1, adequate organ function, and predicted life expectancy >3 months are eligible. Pts will be randomly assigned 2:1 to receive pembro 200 mg IV Q3W + BSC or placebo Q3W + BSC for up to 35 cycles (∼2 years) or until disease progression, unacceptable toxicity, or investigator decision. Randomization will be stratified by geographic region, presence of macrovascular invasion, and α-fetoprotein level. BSC will be provided by the investigator per local treatment practices. Response will be assessed Q6W per RECIST v1.1 by central imaging vendor review. Adverse events (AEs) will be assessed throughout treatment and for 30 days thereafter (90 days for serious AEs) and graded per NCI CTCAE v4.0. Primary objectives are comparison of PFS per RECIST v1.1 by central imaging vendor review and OS between treatment arms. Secondary objectives are comparison of ORR, DOR, DCR, and TTP per RECIST v1.1 by central imaging vendor review, and evaluation of safety and tolerability. Planned enrollment in KEYNOTE-240 is 408 pts across 26 countries.

Clinical trial identification

NCT0270240, March 3, 2016

Legal entity responsible for the study

Merck & Co., Inc., Kenilworth, New Jersey, USA

Funding

Merck & Co., Inc., Kenilworth, New Jersey, USA

Disclosure

R.S. Finn: Consulting/advisory role: Bayer, Novartis, Pfizer, BMS, Merck; Research funding: Bayer (to institution). S.L. Chan: Consulting/advisory role: Medimmune, Novartis. A.X. Zhu: Consulting/advisory role: Merck. J. Knox: Consulting/advisory role: Merck; Research funding: AstraZeneca. A-L. Cheng: Consulting/advisory role: Novartis, Merck Serono, Eisai, Merck, Sharp & Dohme, Ono, BMS, Bayer. A.B. Siegel: Employment and stock: Merck. O. Bautista: Employment and stock: Merck & Co., Inc. M. Kudo: Honoraria: Bayer, Eisai, MSD, Ajinomoto; Research funding: Chugai, Otsuka, Takeda, Taiho, Sumitomo Dainippon, Daiichi Sankyo, MSD, Eisai, Bayer, Abbvie.

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