FDA grants priority review to Keytruda-chemotherapy regimen for esophageal cancer
Pembrolizumab plus fluoropyrimidine-based chemotherapy received FDA priority review for the first-line treatment of locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer, according to a press release.
The FDA based this decision for pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, on data from the phase 3 KEYNOTE-590 trial, presented at the European Society for Medical Oncology Virtual Congress 2020.
As Healio previously reported, the addition of 200 mg IV pembrolizumab given on day 1 of each 3-week cycle for up to 35 cycles to a chemotherapy regimen consisting of 80 mg/m2 cisplatin on day 1 for up to six cycles and 800 mg/m2 5-FU given on days 1 to 5 for up to 35 cycles significantly improved OS and PFS among 749 enrolled patients. The benefit occurred across PD-L1 expression levels and tumor histology subtypes.
Pembrolizumab, which is approved as a monotherapy for the second-line treatment of recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus with PD-L1 expression, also is under investigation for gastric, hepatobiliary, esophageal, pancreatic, colorectal and anal cancers.
“Patients with newly diagnosed esophageal and gastroesophageal junction cancer face an aggressive disease with a poor prognosis, despite the currently available treatment options,” Vicki Goodman, MD, vice president of clinical research at Merck Research Laboratories, said in the manufacturer-issued release. “We look forward to working with the FDA to bring a new option to patients in the first-line setting.”