Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028 (VSports注册入口)
- PMID: 30522700
- DOI: 10.1016/j.ygyno.2018.11.017
Pembrolizumab in patients with programmed death ligand 1-positive advanced ovarian cancer: Analysis of KEYNOTE-028
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Objective: To evaluate safety, tolerability, and antitumor activity of pembrolizumab monotherapy in patients with programmed death ligand 1 (PD-L1)-expressing advanced ovarian cancer enrolled in the multicohort, phase Ib KEYNOTE-028 trial VSports手机版. .
Methods: Key inclusion criteria were age ≥18 years; advanced ovarian epithelial, fallopian tube, or primary peritoneal carcinoma; failure of previous therapy; and tumor PD-L1 positivity. Patients received pembrolizumab (10 mg/kg every 2 weeks) for ≤24 months or until disease progression/intolerable toxicity. Tumor response was assessed per RECIST v1. 1 (investigator review). Adverse events (AEs) were graded using CTCAE version 4. 0. Primary end point was confirmed objective response rate (ORR) per RECIST v1. 1 (investigator review); data cutoff date was February 20, 2017. V体育安卓版.
Results: Twenty-six patients (median age, 57. 5 years) with PD-L1-positive advanced metastatic ovarian cancer received pembrolizumab; 38. 5% had metastatic disease, and 73. 1% previously received ≥3 lines of therapy. Treatment-related AEs (TRAEs) occurred in 19 (73. 1%) patients, most commonly arthralgia (19. 2%), nausea (15 V体育ios版. 4%), and pruritus (15. 4%). One grade 3 TRAE (increased plasma transaminase level) occurred. No deaths and no treatment discontinuations due to TRAEs occurred. After a median follow-up duration of 15. 4 months, ORR was 11. 5% (1 complete response, 2 partial responses); 7 patients (26. 9%) achieved stable disease. Median progression-free and overall survival were 1. 9 (95% CI, 1. 8-3. 5) and 13. 8 (95% CI, 6. 7-18. 8) months, respectively. .
Conclusion: Pembrolizumab conferred durable antitumor activity with manageable safety and toxicity in patients with advanced PD-L1-positive ovarian cancer and is under further investigation in an ongoing phase II trial, KEYNOTE-100. VSports最新版本.
Trial registration: ClinicalTrials. gov NCT02054806 V体育平台登录. .
Keywords: Clinical trials; Gynecologic cancers; Immunotherapy; PD-1; Pembrolizumab VSports注册入口. .
Copyright © 2018. Published by Elsevier Inc V体育官网入口. .
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