Clinical outcomes by baseline metastases in patients with renal cell carcinoma treated with lenvatinib plus pembrolizumab versus sunitinib: Post hoc analysis of the <scp>CLEAR</scp> trial

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.

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Journal
International Journal of Cancer
Published
2024-12-30
DOI
https://doi.org/10.1002/ijc.35288
Citations
10
Primary Topic
Renal cell carcinoma treatment
Type
article
Field-Weighted Citation Impact
4.19

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article

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

Viktor Grünwald, Toshio Takagi, Chinyere E. Okpara, Sylvie Négrier et al.
10 citations
International Journal of Cancer
Renal cell carcinoma treatment
4.19
article

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

Viktor Grünwald, Toshio Takagi, Chinyere E. Okpara, Sylvie Négrier, Masatoshi Eto, T. Powles, Joseph E. Burgents, Daniel Keizman, Ran Xie, Toni K. Choueiri, Se Hoon Park, Rana R. McKay, Robert John Motzer, Sylvie Zanetta, Jae‐Lyun Lee, Jens Bedke, Tomáš Büchler, Daniele Santini, Michael D. Staehler, Cristina Suárez, C. Kollmannsberger
article en
10 citations

Abstract

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.

International Journal of CancerVol. 156(7)
Université Claude Bernard Lyon 1 (FR), Ulsan College (KR), Merck & Co., Inc., Rahway, NJ, USA (United States) (US), BC Cancer Agency (CA), Memorial Sloan Kettering Cancer Center (US), Kyushu University (JP), Tel Aviv University (IL), Royal Free London NHS Foundation Trust (GB), Charles University (CZ), Tel Aviv Sourasky Medical Center (IL), Policlinico Umberto I (IT), Asan Medical Center (KR), Samsung Medical Center (KR), LMU Klinikum (DE), University of California San Diego (US), University of Ulsan (KR), Centre Georges François Leclerc (FR), Centre Léon Bérard (FR), Dana-Farber Cancer Institute (US), Essen University Hospital (DE), München Klinik (DE), Vall d'Hebron Hospital Universitari (ES), Tokyo Women's Medical University (JP), Thomayer University Hospital (CZ), Eisai (United Kingdom) (GB), Eisai (United States) (US), Klinikum Stuttgart (DE), Vall d'Hebron Institute of Oncology (ES), Eisai (Japan) (JP), Sungkyunkwan University (KR), Sapienza University of Rome (IT)
Memorial Sloan-Kettering Cancer Center, Eisai, Eisai Canada
Good health and well-being
Openalex Percentile: Top 5%
Renal cell carcinoma treatment
4.19
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