FDA approves Keytruda for esophageal, gastroesophageal carcinoma
The FDA approved pembrolizumab in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with locally advanced or metastatic esophageal or gastroesophageal carcinoma.
This approval of pembrolizumab (Keytruda, Merck), a PD-1 inhibitor, is indicated for patients whose tumors have an epicenter 1 cm to 5 cm above the gastroesophageal junction and who are not candidates for surgical resection or definitive chemoradiation.
FDA based this approval, in part, on data from the multicenter, randomized KEYNOTE-590 trial, which included 749 patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma who were not candidates for surgical resection or definitive chemoradiation. Researchers randomly assigned patients to receive cisplatin and fluorouracil with either placebo or pembrolizumab.
OS and PFS served as the study’s primary endpoints.
As Healio previously reported, patients assigned pembrolizumab demonstrated significantly longer median OS (12.4 months vs. 9.8 months; HR = 0.73; 95% CI, 0.62-0.86) and PFS (6.3 months vs. 5.8 months; HR = 0.65; 95% CI, 0.55-0.76) than those assigned placebo.
The most common adverse events among patients who received the pembrolizumab regimen included nausea, constipation, diarrhea, vomiting, stomatitis, fatigue/asthenia, decreased appetite and weight loss.
FDA reviewed this drug application — which previously received priority review — with international partners under Project Orbis and using the Real-Time Oncology Review pilot program, which allows for streamlined data submission.