التفاصيل البيبلوغرافية
| العنوان: |
Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study. |
| المؤلفون: |
González-Martín, Antonio1 (AUTHOR) agonzalezma@unav.es, Chung, Hyun Cheol2 (AUTHOR) UNCHUNG8@yuhs.ac, Saada-Bouzid, Esma3 (AUTHOR) Esma.SAADA-BOUZID@nice.unicancer.fr, Yanez, Eduardo4 (AUTHOR) eduardoyanez.icos@gmail.com, Senellart, Helene5 (AUTHOR) Helene.Senellart@ico.unicancer.fr, Cassier, Philippe A.6 (AUTHOR) philippe.cassier@lyon.unicancer.fr, Basu, Bristi7 (AUTHOR) bb313@cam.ac.uk, Corr, Bradley R.8 (AUTHOR) bradley.corr@cuanschutz.edu, Girda, Eugenia9 (AUTHOR) eg535@cinj.rutgers.edu, Dutcus, Corina10 (AUTHOR) Corina_Dutcus@Eisai.com, Okpara, Chinyere E.11 (AUTHOR) Chinyere_Okpara@eisai.net, Ghori, Razi12 (AUTHOR) razi.ghori@merck.com, Jin, Fan12 (AUTHOR) fan.jin@merck.com, Groisberg, Roman12 (AUTHOR) roman.groisberg@merck.com, Lwin, Zarnie13 (AUTHOR) Zarnie.Lwin@health.qld.gov.au |
| المصدر: |
Gynecologic Oncology. Jul2024, Vol. 186, p182-190. 9p. |
| مصطلحات موضوعية: |
*OVARIAN cancer, *CANCER patients, *PEMBROLIZUMAB, *ADVERSE health care events, *OVERALL survival |
| مستخلص: |
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. 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). 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. 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. • We evaluated lenvatinib plus pembrolizumab as fourth-line therapy in 31 patients with advanced ovarian cancer. • Lenvatinib plus pembrolizumab had an objective response rate of 35% by blinded independent central review in this population. • Median duration of response by blinded independent central review was 9.2 (1.5+ to 37.8+) months. • Median progression-free survival was 6.2 months and median overall survival was 21.3 months. • Treatment-related adverse events occurred in 94% of patients (grade 3–4, 77%; grade 5, 3%). [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
Academic Search Index |
