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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
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze III, multicentrická studie
Grantová podpora
P30 CA008748
NCI NIH HHS - United States
Eisai Inc.
Merck Sharp & Dohme LLC
PubMed
39739622
DOI
10.1002/ijc.35288
Knihovny.cz E-zdroje
- MeSH
- chinoliny * aplikace a dávkování terapeutické užití MeSH
- dospělí MeSH
- fenylmočovinové sloučeniny * aplikace a dávkování terapeutické užití MeSH
- humanizované monoklonální protilátky * aplikace a dávkování terapeutické užití MeSH
- karcinom z renálních buněk * farmakoterapie patologie mortalita sekundární MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- nádory ledvin * farmakoterapie patologie mortalita MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- sunitinib * aplikace a dávkování terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie 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
Citace poskytuje Crossref.org
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