Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer
-
- Jacqueline Vuky
- Oregon Health & Science University, Portland, OR
-
- Arjun V. Balar
- Perlmutter Cancer Center, NYU Langone Health, New York, NY
-
- Daniel Castellano
- Hospital Universitario 12 de Octubre, Madrid, Spain
-
- Peter H. O’Donnell
- The University of Chicago, Chicago, IL
-
- Petros Grivas
- Cleveland Clinic, Cleveland OH
-
- Joaquim Bellmunt
- Beth Israel Deaconess Medical Center/IMIM research Institute, Harvard Medical School, Boston, MA
-
- Thomas Powles
- Barts Cancer Institute, Queen Mary University of London, London, United Kingdom
-
- Dean Bajorin
- Memorial Sloan Kettering Cancer Center, New York, NY
-
- Noah M. Hahn
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD
-
- Mary J. Savage
- Merck & Co., Kenilworth, NJ
-
- Xiao Fang
- Merck & Co., Kenilworth, NJ
-
- James Luke Godwin
- Merck & Co., Kenilworth, NJ
-
- Tara L. Frenkl
- Merck & Co., Kenilworth, NJ
-
- Blanca Homet Moreno
- Merck & Co., Kenilworth, NJ
-
- Ronald de Wit
- Erasmus MC Cancer Institute, Rotterdam, the Netherlands
-
- Elizabeth R. Plimack
- Fox Chase Cancer Center, Philadelphia, PA
抄録
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> The phase II single-arm KEYNOTE-052 study evaluated the efficacy and safety of first-line pembrolizumab for patients with locally advanced or metastatic cisplatin-ineligible urothelial carcinoma (UC). </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> Three hundred seventy patients received pembrolizumab 200 mg intravenously every 3 weeks for up to 24 months. Positive tumor programmed death ligand 1 (PD-L1) expression was defined as combined positive score (CPS) ≥ 10. Response was assessed by independent central review every 9 weeks per RECIST v1.1. The primary end point was objective response rate (ORR). </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> At data cutoff (September 26, 2018), the minimum follow-up was 2 years since the last patient enrolled. ORR was 28.6% (95% CI, 24.1% to 33.5%); 33 patients (8.9%) and 73 patients (19.7%) achieved complete and partial response, respectively. The median duration of response was 30.1 months (95% CI, 18.1 months to not reached [NR]); responses lasted ≥ 12 and ≥ 24 months in 67% and 52% of patients, respectively. Forty patients with complete or partial response completed 2 years of study treatment, and 32 had ongoing response at completion. Median overall survival (OS) was 11.3 months (95% CI, 9.7 to 13.1 months), and 12- and 24-month OS rates were 46.9% and 31.2%, respectively. In patients with CPS ≥ 10, ORR was 47.3% (95% CI, 37.7% to 57.0%) and median OS was 18.5 months (95% CI, 12.2 to 28.5 months). In patients with lymph node–only disease, ORR was 49.0% (95% CI, 34.8% to 63.4%), and median OS was 27.0 months (12.4 months to NR). There were no new safety signals. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> First-line pembrolizumab confers meaningful and durable clinical response in cisplatin-ineligible patients with advanced UC and is associated with prolonged OS, particularly with PD-L1 CPS ≥ 10 and lymph node–only disease. </jats:p></jats:sec>
収録刊行物
-
- Journal of Clinical Oncology
-
Journal of Clinical Oncology 38 (23), 2658-2666, 2020-08-10
American Society of Clinical Oncology (ASCO)