(Esophageal Cancer) FDA Approves Pembrolizumab Combined with Chemotherapy

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.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-esophageal-or-gej-carcinoma

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