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Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer

In the August 10, 2020 edition of Journal of Clinical Oncology,  Jacqueline Vuky and colleagues report on the results of a   phase II single-arm trial evaluating the safety and efficacy of first-line pembrolizumab in patients with locally advanced or advanced cisplatin-ineligible urothelial carcinoma (UC).

PURPOSE

KEYNOTE-052 was a phase II single-arm study for evaluating the efficacy and safety of first-line pembrolizumab in patients with locally advanced / metastatic cisplatin-ineligible urothelial carcinoma (UC).

PATIENTS AND METHODS

370 patients were treated with pembrolizumab 200 mg intravenously Q3 eeks for up to 2 years. Positive PD-L1 expression was defined as combined positive score (CPS) 10 or higher. ORR was the primary endpoint.

At data cutoff (September 26, 2018), the minimum follow-up was 24 months since the last patient was enrolled in the study. The overall response rate was 28.6% (95% CI, 24.1% – 33.5%); 33 (8.9%) and 73 patients (19.7%) achieved a CR and PR, respectively. The median DoR was 30.1 months (95% CI, 18.1 months – NR); responses lasted ≥ 12 and ≥ 24 months in 67% and 52% of patients, respectively. 40 patients with CR or PR completed 2 years of study treatment, and 32 patients had ongoing response at completion. The median OS was 11.3 months (95% CI, 9.7 to 13.1 months), and 1-year and 2-year overall survival rates were 46.9% and 31.2%, respectively. In patients with CPS 10 or higher, overall response rate was 47.3% (95% CI, 37.7% to 57.0%) and median overall survival was 18.5 months (95% CI, 12.2 to 28.5 months). In patients with lymph node–only disease, overall response rate was 49.0% (95% CI, 34.8% to 63.4%), and median overall survival was 27.0 months (12.4 months – NR). There were no new safety signals. The authors concluded “first-line pembrolizumab confers meaningful and durable clinical responses in cisplatin-ineligible patients with advanced UC and is associated with prolonged OS, particularly with PD-L1 CPS ≥ 10 and lymph node–only disease.”

Reference:

Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer

https://ascopubs.org/doi/full/10.1200/JCO.19.01213

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