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Efficacy and safety of lenvatinib plus pembrolizumab vs sunitinib in the East Asian subset of patients with advanced renal cell carcinoma from the CLEAR trial

SY. Rha, TK. Choueiri, VB. Matveev, A. Alyasova, SH. Hong, TA. Gordoa, H. Gurney, GA. Bjarnason, T. Buchler, P. Pedrazzoli, T. Takagi, SH. Park, JL. Lee, RF. Perini, CS. He, JA. McKenzie, M. Eto

. 2023 ; 153 (6) : 1241-1250. [pub] 20230609

Language English Country United States

Document type Equivalence Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc23016232

In the CLEAR trial, lenvatinib plus pembrolizumab met study endpoints of superiority vs sunitinib in the first-line treatment of patients with advanced renal cell carcinoma. We report the efficacy and safety results of the East Asian subset (ie, patients in Japan and the Republic of Korea) from the CLEAR trial. Of 1069 patients randomly assigned to receive either lenvatinib plus pembrolizumab, lenvatinib plus everolimus or sunitinib, 213 (20.0%) were from East Asia. Baseline characteristics of patients in the East Asian subset were generally comparable with those of the global trial population. In the East Asian subset, progression-free survival was considerably longer with lenvatinib plus pembrolizumab vs sunitinib (median 22.1 vs 11.1 months; HR 0.38; 95% CI: 0.23-0.62). The HR for overall survival comparing lenvatinib plus pembrolizumab vs sunitinib was 0.71; 95% CI: 0.30-1.71. The objective response rate was higher with lenvatinib plus pembrolizumab vs sunitinib (65.3% vs 49.2%; odds ratio 2.14; 95% CI: 1.07-4.28). Dose reductions due to treatment-emergent adverse events (TEAEs) commonly associated with tyrosine kinase inhibitors occurred more frequently than in the global population. Hand-foot syndrome was the most frequent any-grade TEAE with lenvatinib plus pembrolizumab (66.7%) and sunitinib (57.8%), a higher incidence compared to the global population (28.7% and 37.4%, respectively). The most common grade 3 to 5 TEAEs were hypertension with lenvatinib plus pembrolizumab (20%) and decreased platelet count with sunitinib (21.9%). Efficacy and safety for patients in the East Asian subset were generally similar to those of the global population, except as noted.

Biostatistics Oncology Business Group Eisai Inc Nutley New Jersey USA

Clinical Research Merck and Co Inc Rahway New Jersey USA

Clinical Research Oncology Business Group Eisai Inc Nutley New Jersey USA

Department of Internal Medicine and Medical Therapy University of Pavia and Medical Oncology Unit Fondazione IRCCS Policlinico San Matteo Pavia Italy

Department of Medical Oncology Dana Farber Cancer Institute Boston Massachusetts USA

Department of Medical Oncology Hospital Universitario Ramón y Cajal Madrid Spain

Department of Medical Oncology Macquarie University Sydney New South Wales Australia

Department of Medical Oncology Yonsei Cancer Center Yonsei University Health System Seoul South Korea

Department of Oncology 1st Faculty of Medicine Charles University and Thomayer University Hospital Prague Czech Republic

Department of Oncology Prevoljskiy Region Medical Centre Novgorod Russia

Department of Oncology University of Ulsan College of Medicine Asan Medical Center Seoul South Korea

Department of Urology Federal State Budgetary Institution N N Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation Moscow Russia

Department of Urology Kyushu University Fukuoka Japan

Department of Urology Seoul St Mary's Hospital Seoul South Korea

Department of Urology Tokyo Women's Medical University Hospital Tokyo Japan

Division of Hematology Oncology Department of Medicine Samsung Medical Center Sungkyunkwan University School of Medicine Seoul South Korea

Division of Medical Oncology Department of Medicine Odette Cancer Centre Sunnybrook Health Sciences Centre Toronto Ontario Canada

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$a In the CLEAR trial, lenvatinib plus pembrolizumab met study endpoints of superiority vs sunitinib in the first-line treatment of patients with advanced renal cell carcinoma. We report the efficacy and safety results of the East Asian subset (ie, patients in Japan and the Republic of Korea) from the CLEAR trial. Of 1069 patients randomly assigned to receive either lenvatinib plus pembrolizumab, lenvatinib plus everolimus or sunitinib, 213 (20.0%) were from East Asia. Baseline characteristics of patients in the East Asian subset were generally comparable with those of the global trial population. In the East Asian subset, progression-free survival was considerably longer with lenvatinib plus pembrolizumab vs sunitinib (median 22.1 vs 11.1 months; HR 0.38; 95% CI: 0.23-0.62). The HR for overall survival comparing lenvatinib plus pembrolizumab vs sunitinib was 0.71; 95% CI: 0.30-1.71. The objective response rate was higher with lenvatinib plus pembrolizumab vs sunitinib (65.3% vs 49.2%; odds ratio 2.14; 95% CI: 1.07-4.28). Dose reductions due to treatment-emergent adverse events (TEAEs) commonly associated with tyrosine kinase inhibitors occurred more frequently than in the global population. Hand-foot syndrome was the most frequent any-grade TEAE with lenvatinib plus pembrolizumab (66.7%) and sunitinib (57.8%), a higher incidence compared to the global population (28.7% and 37.4%, respectively). The most common grade 3 to 5 TEAEs were hypertension with lenvatinib plus pembrolizumab (20%) and decreased platelet count with sunitinib (21.9%). Efficacy and safety for patients in the East Asian subset were generally similar to those of the global population, except as noted.
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