- 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.
- 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.
- 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.
- Open-label, single-arm study.