Advanced bladder cancer: pembrolizumab shows good response in cisplatin-ineligible patients

  • Vuky J & al.
  • J Clin Oncol
  • 17 Jun 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Study design

  • Phase 2 single-group KEYNOTE-052 study.
  • 370 patients with advanced cisplatin-ineligible urothelial carcinoma received pembrolizumab for up to 24 months.
  • Funding: MSD.

Key results

  • 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.
  • For patients with lymph node-only disease:
    • ORR was 49.0% and median OS was 27.0 months (12.4 months to NR).
  • 20.8% of patients experienced treatment-related grade ≥3 toxicities; fatigue was most common.
  • Limitations

    • No comparator.