Pembrolizumab in patients with programmed death ligand 1–positive advanced ovarian cancer: Analysis of KEYNOTE-028
| Autor: | Anne Morosky, Janice M. Mehnert, Dominique Berton-Rigaud, Jane Ruman, Daniela Matei, Sarina Anne Piha-Paul, Patrick A. Ott, Andrea Varga, Ping Yang |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
0301 basic medicine Oncology medicine.medical_specialty Nausea Pembrolizumab Carcinoma Ovarian Epithelial Antibodies Monoclonal Humanized B7-H1 Antigen 03 medical and health sciences Antineoplastic Agents Immunological 0302 clinical medicine Primary peritoneal carcinoma Internal medicine medicine Clinical endpoint Humans Adverse effect Aged business.industry Obstetrics and Gynecology Middle Aged medicine.disease Clinical trial 030104 developmental biology Tolerability 030220 oncology & carcinogenesis Female medicine.symptom Ovarian cancer business |
| Zdroj: | Gynecologic Oncology. 152:243-250 |
| ISSN: | 0090-8258 |
| DOI: | 10.1016/j.ygyno.2018.11.017 |
| Popis: | 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. 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. 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 (15.4%), 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. |
| Databáze: | OpenAIRE |
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