5-Year Follow-up Results of Pembrolizumab for Metastatic Urothelial Carcinoma

By Emily Menendez - Last Updated: December 29, 2022

The KEYNOTE-045 and KEYNOTE-052 studies analyzed the safety and efficacy of pembrolizumab for urothelial carcinoma. After (and up to) five years post follow-up, new results show the durability of response to pembrolizumab for patients with metastatic urothelial carcinoma (mUC).

In KEYNOTE-045, patients with mUC that had progressed on platinum-containing chemotherapy were administered a 1:1 dose of pembrolizumab in combination with the investigator’s choice of paclitaxel, docetaxel, or vinflunine. In the KEYNOTE-052 study, cisplatin-ineligible patients with mUC were given first-line pembrolizumab.

542 patients were recruited for KEYNOTE-045, with a median follow-up of 62.9 months. At 48 months, the overall survival rates of pembrolizumab were 16.7%, and 10.1% for chemotherapy treatment. Progression-free survival rates were 9.5% and 2.7%, respectively. The median duration of response (DOR) was 29.7 months for pembrolizumab and 4.4 months for chemotherapy. DOR rates at 36 months were 44.4% and 28.3%, respectively.

The KEYNOTE-052 study enrolled a total of 370 patients, with a median follow-up of 56.3 months. The confirmed overall response rate was 28.9%, and median DOR was 33.4 months. At 36 months, the DOR rate was 44.8%. In both studies, treatment related adverse events were grade 1 or 2 and manageable, which was consistent with previous reports.

At approximately 5 years post follow-up, pembrolizumab was shown to demonstrate efficacy and safety in patients with platinum-resistant mUC and functions as first-line therapy in cisplatin-ineligible patients with mUC.