Lenvatinib plus pembrolizumab for patients with previously treated, advanced, triple-negative breast cancer: Results from the triple-negative breast cancer cohort of the phase 2 LEAP-005 Study.

Autor: Chung HC; Department of Medical Oncology, Yonsei Cancer Center, Yonsei Song-Dang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, Korea., Saada-Bouzid E; Department of Medical Oncology, Cote d'Azur University, Centre Antoine Lacassagne, Nice, France., Longo F; Medical Oncology Department, Ramón y Cajal University Hospital, Instituto Ramón y Cajal de Investigación Sanitaria, Centro de Investigación Biomédica en Red Cáncer, Alcalá University, Madrid, Spain., Yanez E; Oncology-Hematology Unit, University of Frontera, Araucanía, Chile., Im SA; Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea., Castanon E; Department of Oncology, Clínica Universidad de Navarra, Madrid, Spain., Desautels DN; Department of Internal Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada., Graham DM; Experimental Cancer Medicine Team, The Christie National Health Service Foundation Trust, Manchester, UK.; University of Manchester, Manchester, UK., Garcia-Corbacho J; Clinical Institute of Hemato-Oncological Diseases, Hospital Clinic, Barcelona, Spain., Lopez J; Phase I Drug Development Unit, The Royal Marsden Hospital and The Institute of Cancer Research, Sutton, UK., Dutcus C; Eisai Inc., Nutley, New Jersey, USA., Okpara CE; Eisai Ltd., Hatfield, UK., Ghori R; Merck & Co., Inc., Rahway, New Jersey, USA., Jin F; Merck & Co., Inc., Rahway, New Jersey, USA., Groisberg R; Merck & Co., Inc., Rahway, New Jersey, USA., Korakis I; Department of Medicine and Clinical Research Unit, Institut Claudius Regaud/Institut Universitaire du Cancer de Toulouse (IUCT-Oncopole), Toulouse, France.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2024 Oct 01; Vol. 130 (19), pp. 3278-3288. Date of Electronic Publication: 2024 Jun 21.
DOI: 10.1002/cncr.35387
Abstrakt: Background: Novel treatments are needed for patients with advanced, triple-negative breast cancer (TNBC) that progresses or recurs after first-line treatment with chemotherapy. The authors report results from the TNBC cohort of the multicohort, open-label, single-arm, phase 2 LEAP-005 study of lenvatinib plus pembrolizumab in patients with advanced solid tumors (ClinicalTrials.gov identifier NCT03797326).
Methods: Eligible patients had metastatic or unresectable TNBC with disease progression after one or two lines of therapy. Patients received lenvatinib (20 mg daily) plus pembrolizumab (200 mg every 3 weeks; up to 35 cycles). The primary end points were the objective response rate according to Response Evaluation Criteria in Solid Tumors, version 1.1, and safety (adverse events graded by the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.0). Duration of response, progression-free survival, and overall survival were secondary end points.
Results: Thirty-one patients were enrolled. The objective response rate by investigator assessment was 23% (95% confidence interval [CI], 10%-41%). Overall, the objective response rate by blinded independent central review (BICR) was 32% (95% CI, 17%-51%); and, in patients who had programmed cell death ligand 1 combined positive scores ≥10 (n = 8) and <10 (n = 22), the objective response rate was 50% (95% CI, 16%-84%) and 27% (95% CI, 11%-50%), respectively. The median duration of response by BICR was 12.1 months (range, from 3.0+ to 37.9+ months). The median progression-free survival by BICR was 5.1 months (95% CI, 1.9-11.8 months) and the median overall survival was 11.4 months (95% CI, 4.1-21.7 months). Treatment-related adverse events occurred in 94% of patients (grade 3, 52%; grade 4, 0%). One patient died due to a treatment-related adverse event of subarachnoid hemorrhage.
Conclusions: The combination of lenvatinib plus pembrolizumab demonstrated antitumor activity with a manageable safety profile in patients with previously treated, advanced TNBC.
(© 2024 Merck Sharp & Dohme LLC and The Author(s). Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)
Databáze: MEDLINE
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