دورية أكاديمية
Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study.
| العنوان: | Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study. |
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| المؤلفون: | González-Martín A; Department of Medical Oncology, Cancer Center Clinica Universidad de Navarra, Madrid, Spain. Electronic address: agonzalezma@unav.es., Chung HC; Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: UNCHUNG8@yuhs.ac., Saada-Bouzid E; Department of Medical Oncology, Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France. Electronic address: Esma.SAADA-BOUZID@nice.unicancer.fr., Yanez E; Oncology-Hematology Unit, University of Frontera, Araucanía, Chile. Electronic address: eduardoyanez.icos@gmail.com., Senellart H; Centre Rene Gauducheau ICO, Saint-Herblain, France. Electronic address: Helene.Senellart@ico.unicancer.fr., Cassier PA; Centre Léon Bérard, Lyon, France. Electronic address: philippe.cassier@lyon.unicancer.fr., Basu B; Cancer Research UK Cambridge Centre, University of Cambridge, Cambridge, UK. Electronic address: bb313@cam.ac.uk., Corr BR; University of Colorado Cancer Center, Aurora, CO, USA. Electronic address: bradley.corr@cuanschutz.edu., Girda E; Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA. Electronic address: eg535@cinj.rutgers.edu., Dutcus C; Eisai Inc., Nutley, NJ, USA. Electronic address: Corina_Dutcus@Eisai.com., Okpara CE; Eisai Ltd., Hatfield, United Kingdom. Electronic address: Chinyere_Okpara@eisai.net., Ghori R; Merck & Co., Inc., Rahway, NJ, USA. Electronic address: razi.ghori@merck.com., Jin F; Merck & Co., Inc., Rahway, NJ, USA. Electronic address: fan.jin@merck.com., Groisberg R; Merck & Co., Inc., Rahway, NJ, USA. Electronic address: roman.groisberg@merck.com., Lwin Z; Royal Brisbane and Women's Hospital and University of Queensland, Herston, Queensland, Australia. Electronic address: Zarnie.Lwin@health.qld.gov.au. |
| المصدر: | Gynecologic oncology [Gynecol Oncol] 2024 May 07; Vol. 186, pp. 182-190. Date of Electronic Publication: 2024 May 07. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Academic Press Country of Publication: United States NLM ID: 0365304 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1095-6859 (Electronic) Linking ISSN: 00908258 NLM ISO Abbreviation: Gynecol Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York, Academic Press. |
| مستخلص: | Objectives: The phase 2, multicohort, open-label LEAP-005 study evaluated lenvatinib plus pembrolizumab in patients with previously treated advanced solid tumors. We report outcomes from the ovarian cancer cohort. Methods: Eligible patients had metastatic/unresectable ovarian cancer and had received 3 previous lines of therapy. Patients received lenvatinib 20 mg/day plus pembrolizumab 200 mg every 3 weeks. Treatment continued until progression, unacceptable toxicity, or (for pembrolizumab) completion of 35 cycles. Primary endpoints were objective response rate (ORR) per RECIST version 1.1 and safety. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Results: Thirty-one patients were enrolled. 39% had high grade serous ovarian cancer, 23% were platinum-sensitive, 55% were platinum-resistant, 23% were platinum-refractory, and 84% had tumors that had a PD-L1 combined positive (CPS) score ≥1. ORR (95% CI) was 26% (12%-45%) by investigator assessment and 35% (19%-55%) by blinded independent central review (BICR). Per BICR, median DOR was 9.2 (1.5+ to 37.8+) months. ORRs (95% CI) by BICR were 35% (9/26 patients; 17%-56%) for PD-L1 CPS ≥ 1 disease and 50% (2/4 patients; 7%-93%) for PD-L1 CPS < 1 disease. Median (95% CI) PFS by BICR and OS were 6.2 (4.0-8.5) months and 21.3 (11.7-32.3) months, respectively. Treatment-related AEs occurred in 94% of patients (grade 3-4, 77%). One patient died from treatment-related hypovolemic shock. Conclusions: Lenvatinib plus pembrolizumab demonstrated antitumor activity as fourth line therapy in patients with advanced ovarian cancer, and no unanticipated safety signals were identified. Responses were observed regardless of PD-L1 status. (Copyright © 2024. Published by Elsevier Inc.) |
| فهرسة مساهمة: | Keywords: Immune checkpoint inhibitors; Ovarian neoplasms; Phase 2 clinical trial; Protein kinase inhibitors |
| تواريخ الأحداث: | Date Created: 20240508 Latest Revision: 20240508 |
| رمز التحديث: | 20240509 |
| DOI: | 10.1016/j.ygyno.2024.04.011 |
| PMID: | 38718741 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1095-6859 |
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| DOI: | 10.1016/j.ygyno.2024.04.011 |