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Clinical outcomes by baseline metastases in patients with renal cell carcinoma treated with lenvatinib plus pembrolizumab versus sunitinib: Post hoc analysis of the CLEAR trial
V. Grünwald, RR. McKay, T. Buchler, M. Eto, SH. Park, T. Takagi, S. Zanetta, D. Keizman, C. Suárez, S. Négrier, JL. Lee, D. Santini, J. Bedke, M. Staehler, C. Kollmannsberger, TK. Choueiri, RJ. Motzer, JE. Burgents, R. Xie, CE. Okpara, T. Powles
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Clinical Trial, Phase III, Multicenter Study
Grant support
P30 CA008748
NCI NIH HHS - United States
Eisai Inc.
Merck Sharp & Dohme LLC
PubMed
39739622
DOI
10.1002/ijc.35288
Knihovny.cz E-resources
- MeSH
- Quinolines * administration & dosage therapeutic use MeSH
- Adult MeSH
- Phenylurea Compounds * administration & dosage therapeutic use MeSH
- Antibodies, Monoclonal, Humanized * administration & dosage therapeutic use MeSH
- Carcinoma, Renal Cell * drug therapy pathology mortality secondary MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Metastasis MeSH
- Kidney Neoplasms * drug therapy pathology mortality MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Sunitinib * administration & dosage therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
Lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib in treatment of advanced renal cell carcinoma (aRCC) in the phase 3 CLEAR study. We report results of an exploratory post hoc analysis of tumor response data based on baseline metastatic characteristics of patients who received lenvatinib plus pembrolizumab versus sunitinib, at the final overall survival analysis time point of CLEAR (cutoff: July 31, 2022). Treatment-naïve adults with aRCC were randomized to: lenvatinib (20 mg PO QD in 21-day cycles) plus pembrolizumab (n = 355; 200 mg IV Q3W); lenvatinib plus everolimus (not reported here); or sunitinib (n = 357; 50 mg PO QD; 4 weeks on/2 weeks off). The most common (lenvatinib plus pembrolizumab; sunitinib, respectively) metastatic site was lung (71.0%; 63.9%), followed by lymph node (45.6%; 43.7%), bone (22.5%; 24.9%), and liver (17.7%; 19.6%). Across treatment arms, ≥65% had two or more metastatic organs/sites involved, >80% of patients had nontarget lesions, and ~45% had baseline sums of diameters of target lesions ≥60 mm. Lenvatinib plus pembrolizumab demonstrated greater progression-free survival, objective response rate, and duration of response versus sunitinib across evaluable subgroups regardless of site or size of baseline metastasis or number of metastatic sites at baseline. Overall survival generally trended to favor lenvatinib plus pembrolizumab versus sunitinib; and tumor shrinkage was greater across sites (lung, lymph node, liver, and bone) for patients in the lenvatinib-plus-pembrolizumab arm versus the sunitinib arm. These results further support lenvatinib plus pembrolizumab as a standard-of-care in patients with aRCC regardless of site or size of baseline metastasis or the number of metastatic sites.
Biostatistics Eisai Inc Nutley New Jersey USA
Clinical Research Eisai Ltd Hatfield UK
Department of Medical Oncology A Policlinico Umberto 1 La Sapienza Università di Roma Rome Italy
Department of Medical Oncology BC Cancer Vancouver Cancer Centre Vancouver British Columbia Canada
Department of Medical Oncology Dana Farber Cancer Institute Boston Massachusetts USA
Department of Medicine Memorial Sloan Kettering Cancer Center New York New York USA
Department of Oncology Georges François Leclerc Cancer Centre Dijon France
Department of Oncology The Royal Free NHS Trust London UK
Department of Urology Kyushu University Fukuoka Japan
Department of Urology Tokyo Women's Medical University Tokyo Japan
Department of Urology University Hospital of Munich Munich Germany
Division of Hematology Oncology University of California San Diego La Jolla California USA
Global Clinical Development Merck and Co Inc Rahway New Jersey USA
References provided by Crossref.org
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