Pembrolizumab Yields Meaningful Benefit in Advanced Urothelial Cancer
Pembrolizumab was active in patients with advanced or metastatic cisplatin-ineligible urothelial carcinoma, according to long-term results from the phase 2 KEYNOTE-052 clinical trial (J Clin Oncol. 2020 Jun 17. Epub ahead of print).
“[KEYNOTE-052] evaluated the efficacy and safety of first-line pembrolizumab for patients with locally advanced or metastatic cisplatin-ineligible urothelial carcinoma,” explained Jacqueline Vuky, MD, Oregon Health & Science University, Portland, OR, and co-investigators.
A total of 372 patients were enrolled in the study and given pembrolizumab 200 mg every 3 weeks for up to 24 months. Data cutoff was September 2018 and the minimum follow-up period was 2 years.
The primary end point was the objective response rate (ORR), which was 28.6%, including 33 patients with complete responses and 73 patients with partial responses.
The median overall survival (OS) was 11.3 months, and the 12-month OS rate was 46.9%. Furthermore, the 24-month OS rate was 31.2%.
Among patients with combined positive score (CPS) ≥10, the ORR was 47.3% and the median OS was 18.5 months. Those with lymph node-only disease had an ORR of 49.0% and a median OS of 27.0 months.
Dr Vuky et al did not find any new safety signals.
“First-line pembrolizumab confers meaningful and durable clinical response in cisplatin-ineligible patients with advanced [urothelial carcinoma] and is associated with prolonged OS, particularly with PD-L1 CPS ≥ 10 and lymph node–only disease,” they concluded. —Kaitlyn Manasterski