On March 22, 2021, the Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation.
- How many patients were evaluated for this study? 749
- What is the study ID? KEYNOTE-590 (NCT03189719)
- How were patients randomized? (1:1) to pembrolizumab in combination with cisplatin and fluorouracil or placebo with cisplatin and fluorouracil, until unacceptable toxicity or disease progression.
- What were the results of the study? Statistically significant improvement in overall survival (OS) and progression-free survival (PFS) for patients randomized to pembrolizumab with chemotherapy.
- Median OS for the pembrolizumab arm: 12.4 months (95% CI: 10.5, 14.0)
- Median OS for the chemotherapy arm: 9.8 months (95% CI: 8.8, 10.8) (HR 0.73; 95% CI: 0.62, 0.86; p<0.0001).
- Median PFS for the pembrolizumab arm: 6.3 months (95% CI: 6.2, 6.9)
- Median PFS for the chemotherapy arm: 5.8 months (95% CI: 5.0, 6.0) (HR 0.65; 95% CI: 0.55, 0.76; p<0.0001).
- What were the most common adverse reactions? In ≥20% of patients who received the pembrolizumab combination were nausea, constipation, diarrhea, vomiting, stomatitis, fatigue/asthenia, decreased appetite, and weight loss.
- What is the recommended pembrolizumab dose for esophageal cancer? 200 mg every 3 weeks or 400 mg every 6 weeks.
Reference:
- FDA approves pembrolizumab for esophageal or GEJ carcinoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-esophageal-or-gej-carcinoma (accessed April 13, 2021)
