- The US Food and Drug Administration (FDA) has approved pembrolizumab for the treatment of locally advanced or metastatic squamous cell carcinoma of the esophagus in patients who have failed ≥1 line of systemic therapy and have a programmed death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10.
- PD-L1 status must be determined using the FDA-approved PD-L1 IHC 22C3 pharmDx kit.
Why this matters
- This is the first immunotherapy to be approved for esophageal cancer.
- The approval was based on 2 trials.
- 628 patients randomly assigned to pembrolizumab every 3 weeks or a control arm of paclitaxel, docetaxel, or irinotecan (investigator’s choice).
- OS was better in the pembrolizumab group in patients with CPS ≥10 (HR, 0.64; 95% CI, 0.46-0.90). Median OS was 10.3 vs 6.7 months.
- Single arm, open-label trial of 121 patients that progressed on or after ≥2 systemic treatments. Other criteria and dosage were similar to KEYNOTE-181.
- Among 35 patients with PD-L1 CPS ≥10, overall response rate was 20% (95% CI, 8%-37%). Response duration ranged from 4.2 to 25.1+ months. 71% of responses lasted ≥6 months and 57% lasted ≥12 months.
- Prescribing information.