(Esophageal Cancer) FDA Approves Pembrolizumab Combined with Chemotherapy
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On March 22, 2021, the US Food and Drug Administration (FDA) approved pembrolizumab combined with platinum-based or pyrimidine fluoride chemotherapy for patients with locally advanced or metastatic esophageal cancer or gastroesophageal junction (GEJ) carcinoma who are not candidates for surgical resection or definitive chemoradiation.
KEYNOTE-590 Trial (NCT03189719)
The efficacy of this combination was evaluated in the KEYNOTE-590 trial — a multicenter, randomized, placebo-controlled trial enrolling 749 patients with locally advanced or metastatic esophageal cancer or GEJ carcinoma who were not candidates for surgical resection or definitive chemoradiation. PD-L1 status was assessed using the PD-L1 IHC 22C3 pharmDx kit. Patients were randomized 1:1 to pembrolizumab plus chemotherapy or placebo, with treatment continuing until disease progression or intolerable side effects.
Efficacy Results
The primary endpoints were overall survival (OS) and progression-free survival (PFS). The pembrolizumab plus chemotherapy group showed significant improvements in both OS and PFS:
- Median OS: Pembrolizumab + chemotherapy: 12.4 months / Placebo: 9.8 months
- Median PFS: Pembrolizumab + chemotherapy: 6.3 months / Placebo: 5.8 months
Common Side Effects
In the KEYNOTE-590 trial, the most common adverse events (≥20%) in the pembrolizumab plus chemotherapy group were: nausea, constipation, diarrhea, vomiting, stomatitis, fatigue/asthenia, decreased appetite, and weight loss.
Recommended Dosing
The recommended dose of pembrolizumab for esophageal cancer is 200 mg every 3 weeks or 400 mg every 6 weeks.
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