Bladder cancer: switch-maintenance pembrolizumab shows response, extends PFS

  • Galsky MD & al.
  • J Clin Oncol
  • 9 Apr 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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).

Limitations

  • Small sample size of the subsets.