The FDA has approved pembrolizumab (Keytruda) for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (combined positive score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after ≥1 prior line of systemic therapy.
The approval is based on findings from the phase III KEYNOTE-181 and phase II KEYNOTE-180 trials, in which pembrolizumab led to an improvement in median overall survival (OS) compared with chemotherapy and elicited encouraging overall response rates (ORR) in patients with PD-L1–positive esophageal cancer, respectively.
"Historically, patients with advanced esophageal cancer have had limited treatment options, particularly after their disease has progressed," Jonathan Cheng, MD, vice president, oncology clinical research, Merck Research Laboratories, the developer of the PD-1 inhibitor., stated in a press release. "With this approval, Keytruda is now the first anti-PD-1 therapy approved for the treatment of previously-treated patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS ≥10), providing an important new monotherapy option for physicians and patients in the United States."
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