Article (Scientific journals)
Lenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma: Final Prespecified Overall Survival Analysis of CLEAR, a Phase III Study.
Motzer, Robert J; Porta, Camillo; Eto, Masatoshi et al.
2024In Journal of Clinical Oncology, p. 2301569
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Keywords :
Cancer Research; Oncology
Abstract :
[en] Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We present the final prespecified overall survival (OS) analysis of the open-label, phase III CLEAR study in treatment-naïve patients with advanced renal cell carcinoma (aRCC). With an additional follow-up of 23 months from the primary analysis, we report results from the lenvatinib plus pembrolizumab versus sunitinib comparison of CLEAR. Treatment-naïve patients with aRCC were randomly assigned to receive lenvatinib (20 mg orally once daily in 21-day cycles) plus pembrolizumab (200 mg intravenously once every 3 weeks) or sunitinib (50 mg orally once daily [4 weeks on/2 weeks off]). At this data cutoff date (July 31, 2022), the OS hazard ratio (HR) was 0.79 (95% CI, 0.63 to 0.99). The median OS (95% CI) was 53.7 months (95% CI, 48.7 to not estimable [NE]) with lenvatinib plus pembrolizumab versus 54.3 months (95% CI, 40.9 to NE) with sunitinib; 36-month OS rates (95% CI) were 66.4% (95% CI, 61.1 to 71.2) and 60.2% (95% CI, 54.6 to 65.2), respectively. The median progression-free survival (95% CI) was 23.9 months (95% CI, 20.8 to 27.7) with lenvatinib plus pembrolizumab and 9.2 months (95% CI, 6.0 to 11.0) with sunitinib (HR, 0.47 [95% CI, 0.38 to 0.57]). Objective response rate also favored the combination over sunitinib (71.3% v 36.7%; relative risk 1.94 [95% CI, 1.67 to 2.26]). Treatment-emergent adverse events occurred in >90% of patients who received either treatment. In conclusion, lenvatinib plus pembrolizumab achieved consistent, durable benefit with a manageable safety profile in treatment-naïve patients with aRCC.
Disciplines :
Oncology
Author, co-author :
Motzer, Robert J ;  Memorial Sloan Kettering Cancer Center, New York, NY
Porta, Camillo;  University of Bari "A. Moro," Bari, Italy ; University of Pavia, Pavia, Italy
Eto, Masatoshi;  Kyushu University, Fukuoka, Japan
Powles, Thomas ;  The Royal Free NHS Trust, London, United Kingdom
Grünwald, Viktor ;  University Hospital Essen, Essen, Germany
Hutson, Thomas E ;  Texas Oncology, Dallas, TX
Alekseev, Boris;  P.A. Herzen Moscow Oncological Research Institute, Moscow, Russia
Rha, Sun Young ;  Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea
Merchan, Jaime ;  University of Miami Sylvester Comprehensive Cancer Center, Miami, FL
Goh, Jeffrey C ;  ICON Research, South Brisbane & Queensland University of Technology, Brisbane, Queensland, Australia
Lalani, Aly-Khan A ;  Juravinski Cancer Centre, McMaster University, Hamilton, Ontario, Canada
De Giorgi, Ugo ;  IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy
Melichar, Bohuslav;  Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic
Hong, Sung-Hoo ;  Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea
Gurney, Howard ;  Macquarie University, Sydney, NSW, Australia
Méndez-Vidal, María José ;  Maimonides Institute for Biomedical research of Cordoba (IMIBIC) Hospital Universitario Reina Sofía, Medical Oncology Department, Córdoba, Spain
Kopyltsov, Evgeny;  State Institution of Healthcare "Regional Clinical Oncology Dispensary," Omsk, Russia
Tjulandin, Sergei ;  N N Blokhin National Medical Research Center for Oncology, Ministry of Health of the Russian Federation, Moscow, Russia
Gordoa, Teresa Alonso ;  Hospital Universitario Ramón y Cajal, Madrid, Spain
Kozlov, Vadim;  State budgetary Health Care Institution "Novosibirsk Regional Clinical Oncology Dispensary," Novosibirsk, Russia
Alyasova, Anna;  Prevoljskiy Region Medical Centre, Novgorod, Russia
Winquist, Eric ;  Western University, London, Ontario, Canada
Maroto, Pablo;  Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Kim, Miso ;  Seoul National University Hospital, Seoul, South Korea
Peer, Avivit;  Rambam Health Care Campus, Haifa, Israel
Procopio, Giuseppe ;  Fondazione IRCCS Istituto Nazionale Tumori Milano, Milan, Italy
Takagi, Toshio;  Tokyo Women's Medical University, Tokyo, Japan
Wong, Shirley;  Western Health, Melbourne, Victoria, Australia
Bedke, Jens ;  Department of Urology and Transplantation Surgery, Klinikum Stuttgart, Stuttgart, Germany
Schmidinger, Manuela;  Department of Urology, Medical University of Vienna, Vienna, Austria
Rodriguez-Lopez, Karla;  Merck & Co, Inc, Rahway, NJ
Burgents, Joseph;  Merck & Co, Inc, Kenilworth, NJ
He, Cixin;  Eisai Inc, Nutley, NJ
Okpara, Chinyere E ;  Eisai Ltd, Hatfield, UK
McKenzie, Jodi ;  Eisai Inc, Nutley, NJ
Choueiri, Toni K ;  Dana-Farber Cancer Institute, Boston, MA
CLEAR Trial Investigators
More authors (27 more) Less
Other collaborator :
Gennigens, Christine  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service d'oncologie médicale
Language :
English
Title :
Lenvatinib Plus Pembrolizumab Versus Sunitinib in First-Line Treatment of Advanced Renal Cell Carcinoma: Final Prespecified Overall Survival Analysis of CLEAR, a Phase III Study.
Publication date :
16 January 2024
Journal title :
Journal of Clinical Oncology
ISSN :
0732-183X
eISSN :
1527-7755
Publisher :
American Society of Clinical Oncology (ASCO), United States
Pages :
JCO2301569
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 02 April 2024

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