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On Thursday afternoon, Merck & Co Inc (NYSE: MRK) agreed to withdraw the U.S. accelerated approval indication for third-line gastric cancer indication for its blockbuster Keytruda (pembrolizumab) after late-stage confirmatory trials failed to show clinical benefit.
The indication covers recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1, with disease progression on or after two or more prior lines of therapy.
The decision was made in consultation with the FDA following the April 29 Oncologic Drugs Advisory Committee that voted 6-2 against keeping Keytruda as a third-line treatment for gastric cancer.
Keytruda as a monotherapy failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a Phase 3 study.
The accelerated approval for Keytruda first came in September 2017. However, Keytruda still has three other accelerated approval indications in different types of stomach cancer, all of which were approved based on tumor response rate and durability of response.
Merck’s clinical program in gastric cancer includes three first-line Phase 3 trials, KEYNOTE-811, KEYNOTE-859, and LEAP-015, as well as KEYNOTE-585 in the neoadjuvant and adjuvant setting.
Price Action: MRK shares are up 0.14% at $78.10 premarket on the last check Friday.
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