The FDA has accepted for review a supplemental Biologics License Application for pembrolizumab, an anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have already received two or more lines of chemotherapy.
The application submitted to the FDA is seeking approval for pembrolizumab monotherapy in previously treated patients at a fixed dose of 200 mg administered intravenously every 3 weeks. The application is based on data from cohort one of the phase II KEYNOTE-059 trial investigating pembrolizumab in heavily-pretreated patients with recurrent or advanced gastric or GEJ adenocarcinoma that has progressed after two or more lines of chemotherapy. Data from cohort one of KEYNOTE-059 was presented at the 2017 ASCO Annual Meeting in Chicago, June 2-6 (Abstract 4003).
Pembrolizumab is being evaluated in multiple clinical trials in more than 30 tumor types, including multiple gastrointestinal cancers. Specific to gastric cancer, pembrolizumab is being investigated as a monotherapy and in combination with other cancer treatments across multiple lines of therapy. To date, this includes four gastric cancer registration-enabling studies, and numerous other gastrointestinal cancer studies are underway.?