- In patients with metastatic urothelial cancer, initiation of pembrolizumab immediately after completion of first-line chemotherapy shows good response and extends PFS.
Why this matters
- Maintenance avelumab was recently approved in this setting.
- The current results also support switch-maintenance strategy in these patients.
- Double-blind, phase 2 GU14-182 study: 108 patients with metastatic urothelial cancer who achieved stable disease or partial response with first-line platinum-based chemotherapy were randomly assigned to either pembrolizumab (n=55) or placebo (n=53).
- Funding: MSD; Tisch Cancer Institute Cancer Center.
- The median follow-up was 12.9 months.
- In the pembrolizumab vs placebo group:
- The objective response rate was 23% vs 10%.
- The complete response rate was 9% vs 0%.
- Treatment-emergent grade 3-4 adverse event rate was 59% vs 38%.
- The median PFS was 5.4 vs 3.0 months (HR, 0.65; log-rank P=.04; maximum efficiency robust test P=.039).
- The median OS was 22 vs 18.7 months.
- No significant interaction between programmed death-ligand 1 combined positive score ≥10 and treatment group for PFS (P=.8) or OS (P=.9).
- Small sample size of the subsets.