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Randomized Phase 3 LEAP-012 Study: Transarterial Chemoembolization With or Without Lenvatinib Plus Pembrolizumab for Intermediate-Stage Hepatocellular Carcinoma Not Amenable to Curative Treatment |
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Cardiovasc Intervent Radiol. 2022 Feb 4. doi: 10.1007/s00270-021-03031-9.Online ahead of print.
Josep M Llovet 1 2 3, Arndt Vogel 4, David C Madoff 5, Richard S Finn 6, Sadahisa Ogasawara 7, Zhenggang Ren 8, Kalgi Mody 9, Jerry J Li 10, Abby B Siegel 10, Leonid Dubrovsky 10, Masatoshi Kudo 11
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Author information
- 1Mount Sinai Liver Cancer Program, Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, Icahn (East) Building, 11th Floor, Room 11-70A, 1425 Madison Ave, New York, NY, 10029, USA. josep.llovet@mountsinai.org.
- 2Translational Research in Hepatic Oncology, IDIBAPS, Hospital Clinic Barcelona, University of Barcelona, Barcelona, Catalonia, Spain. josep.llovet@mountsinai.org.
- 3Institució Catalana d'Estudis Avançats (ICREA), Barcelona, Spain. josep.llovet@mountsinai.org.
- 4Hannover Medical School, Hannover, Germany.
- 5Yale School of Medicine and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT, USA.
- 6David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
- 7Graduate School of Medicine, Chiba University, Chiba, Japan.
- 8Zhongshan Hospital Fudan University, Shanghai, China.
- 9Eisai Inc, Woodcliff Lake, NJ, USA.
- 10Merck & Co., Inc, Kenilworth, NJ, USA.
- 11School of Medicine, Kindai University, Osaka, Japan.
Abstract
Purpose: Transarterial chemoembolization (TACE) is the standard of care for patients with intermediate-stage hepatocellular carcinoma (HCC). Lenvatinib, a multikinase inhibitor, and pembrolizumab, a PD-1 inhibitor, have shown efficacy and tolerability in patients with HCC, and adding this combination to TACE may enhance clinical benefit.
Protocol: LEAP-012 is a prospective, double-blind randomized phase 3 study. Adults with confirmed HCC localized to the liver without portal vein thrombosis and not amenable to curative treatment, ≥ 1 measurable tumor per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1), Eastern Cooperative Oncology Group performance status 0 or 1, Child-Pugh class A and no previous systemic treatment for HCC are eligible. Patients will be randomly assigned to lenvatinib once daily plus pembrolizumab every 6 weeks plus TACE or placebos plus TACE. Dual primary endpoints are overall survival and progression-free survival per RECIST 1.1 by blinded independent central review (BICR). Secondary endpoints are progression-free survival, objective response rate, disease control rate, duration of response and time to progression per modified RECIST by BICR; objective response rate, disease control rate, duration of response and time to progression per RECIST 1.1 by BICR; and safety.
Statistics: The planned sample size, 950 patients, was calculated to permit accumulation of sufficient overall survival events in 5 years to achieve 90% power for the overall survival primary endpoint.
Discussion: LEAP-012 will evaluate the clinical benefit of adding lenvatinib plus pembrolizumab to TACE in patients with intermediate-stage HCC not amenable to curative treatment. ClinicalTrials.gov NCT04246177.
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