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Vuky J , Balar AV , Castellano D , O'Donnell PH , Grivas P , Bellmunt J , Powles T , Bajorin D , Hahn NM , Savage MJ , Fang X , Godwin JL , Frenkl TL , Homet Moreno B , de Wit R , Plimack ER
Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer
J Clin Oncol. 2020 Aug 10;38(23) :2658-2666
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PURPOSE: 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). PATIENTS AND METHODS: 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). RESULTS: 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. CONCLUSION: 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.
1527-7755 Vuky, Jacqueline Balar, Arjun V Castellano, Daniel O'Donnell, Peter H Grivas, Petros Bellmunt, Joaquim Powles, Thomas Bajorin, Dean Hahn, Noah M Savage, Mary J Fang, Xiao Godwin, James Luke Frenkl, Tara L Homet Moreno, Blanca de Wit, Ronald Plimack, Elizabeth R Journal Article United States J Clin Oncol. 2020 Jun 17:JCO1901213. doi: 10.1200/JCO.19.01213.