- Frontline pembrolizumab achieves meaningful and durable clinical response in cisplatin-ineligible patients with advanced urothelial carcinoma and is associated with high OS at 2 years.
- Significant responses were seen in patients with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥10 and lymph node-only disease.
Why this matters
- Cisplatin-ineligible patients have poor prognosis.
- Phase 2 single-group KEYNOTE-052 study.
- 370 patients with advanced cisplatin-ineligible urothelial carcinoma received pembrolizumab for up to 24 months.
- Funding: MSD.
- Objective response rate (ORR) was 28.6%.
- 8.9% of patients achieved complete response and 19.7% had partial responses.
- The median duration of response (DOR) was 30.1 months.
- 52.0% of patients with a response had a DOR ≥24 months.
- Median OS was 11.3 (95% CI, 9.7-13.1) months, and 24-month OS rate was 31.2%.
- For patients with PD-L1 CPS ≥10:
- ORR was 47.3%, 20.0% of patients had complete response, and DOR was not reached (NR).
- For patients with PD-L1 CPS
- ORR was 20.3% and median DOR was 18.2 months.
- ORR was 49.0% and median OS was 27.0 months (12.4 months to NR).
- No comparator.