TY - JOUR
T1 - Pembrolizumab in patients with programmed death ligand 1–positive advanced ovarian cancer
T2 - Analysis of KEYNOTE-028
AU - Varga, Andrea
AU - Piha-Paul, Sarina
AU - Ott, Patrick A.
AU - Mehnert, Janice M.
AU - Berton-Rigaud, Dominique
AU - Morosky, Anne
AU - Yang, Ping
AU - Ruman, Jane
AU - Matei, Daniela
N1 - Funding Information:
Funding for this research was provided by Merck Sharp & Dohme Corp ., a subsidiary of Merck & Co, Inc., Kenilworth, NJ, USA. This trial was designed by Merck representatives and academic advisors. Data were analyzed and interpreted by authors and representatives of the sponsor. Data were collected by investigators and site personnel and analyzed and interpreted by authors and Merck representatives. All authors had access to the data. Medical writing and editorial assistance was provided by ApotheCom and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc., Kenilworth, NJ, USA
Funding Information:
Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc., Kenilworth, NJ, USA. This trial was designed by Merck representatives and academic advisors. Data were analyzed and interpreted by authors and representatives of the sponsor. Data were collected by investigators and site personnel and analyzed and interpreted by authors and Merck representatives. All authors had access to the data. Medical writing and editorial assistance was provided by ApotheCom and funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc., Kenilworth, NJ, USA.
Publisher Copyright:
© 2018
PY - 2019/2
Y1 - 2019/2
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Gynecologic cancers
KW - Immunotherapy
KW - PD-1
KW - Pembrolizumab
UR - http://www.scopus.com/inward/record.url?scp=85057545727&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85057545727&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2018.11.017
DO - 10.1016/j.ygyno.2018.11.017
M3 - Article
C2 - 30522700
AN - SCOPUS:85057545727
SN - 0090-8258
VL - 152
SP - 243
EP - 250
JO - Gynecologic oncology
JF - Gynecologic oncology
IS - 2
ER -
