FDA Approves Keytruda With Chemotherapy for Esophageal, Gastroesophageal Cancers

The Food and Drug Administration (FDA) has just announced approval of Keytruda (pembrolizumab) combined with platinum and fluoropyrimidine-based chemotherapy for the treatment of patients who have metastatic or locally advanced esophageal or gastroesophageal carcinoma and cannot undergo resection or definitive chemoradiation.

This approval comes following the KEYNOTE-590 trial, which evaluated 749 patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma, who could not have resection or definitive chemoradiation. Patients were randomized to receive either Keytruda in combination with cisplatin and fluorouracil or a placebo with cisplatin and fluorouracil. Treatment was given until disease progressed or side effects became unacceptable.

Main outcomes of the study were overall survival and progression free survival, or the length of time during and after treatment that the cancer does not worsen.

Median overall survival outcome was 12.4 months and 9.8 months for those receiving Keytruda combination and those receiving the placebo combination, respectively.Median progression free survival was 6.3 with the Keytruda combination and 5.8 months with the placebo combination.

The recommended dosage of Keytruda for esophageal cancer, is either 200mg every three weeks or 400mg every six weeks.

At least 20% of patients receiving Keytruda experienced side effects such as nausea, constipation, diarrhea, vomiting, mouth and lip swelling, fatigue/asthenia, decreased appetite and weight loss.

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