Cervical cancer: the study behind FDA approval of pembrolizumab

  • Chung HC & al.
  • J Clin Oncol
  • 3 Apr 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Pembrolizumab shows antitumor activity and manageable safety in patients with advanced cervical cancer who progressed on chemotherapy.

Why this matters

  • These data led to FDA approval of pembrolizumab in patients with advanced cervical cancer who progressed on chemotherapy.

Study design

  • Data for 98 patients with previously treated advanced cervical cancer in the multicenter, phase 2 pembrolizumab KEYNOTE-158 basket study.
  • Funding: Merck & Co., Inc., Kenilworth, NJ, USA.

Key results

  • 83.7% of patients had programmed death-ligand 1 (PD-L1)-positive tumors.
  • Median follow-up, 10.2 months.
  • Overall response rate (ORR) was 12.2% (95% CI, 6.5%-20.4%).
  • All responses were observed in PD-L1-positive patients.
  • ORR was 14.6% in PD-L1-positive patients (95% CI, 7.8%-24.2%) and 14.3% in those who received ≥1 lines of chemotherapy (95% CI, 7.4%-24.1%).
  • Median time to response was 2.1 months.
  • Disease control rate was 30.6% overall (95% CI, 21.7%-40.7%) and 32.9% (95% CI, 22.9%-44.2%) in PD-L1-positive patients.
  • Median PFS, 2.1 (95% CI, 2.0-2.2) months; estimated 6-month PFS rate, 25.0%.
  • Median duration of response, not reached (range, ≥3.7 to ≥18.6 months).
  • Treatment-related adverse event (TRAE) rate was 65.3%; most common were hypothyroidism, decreased appetite, and fatigue.
  • 12.2% of patients had grade 3-4 TRAEs.

Limitations

  • Open-label, single-arm study.

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