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# Keytruda Hits Endpoint in Cervical Cancer Trial
- URL: https://www.fdaweb.com/keytruda-hits-endpoint-in-cervical-cancer-trial/
- Published: 2023-07-19T12:00:00.000Z
- Updated: 2026-09-14T18:45:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154911

Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy demonstrated a significantly significant and clinically meaningful improvement in progression-free survival in the Phase 3 KEYNOTE A-18 trial as a treatment for newly-diagnosed patients with high-risk locally advanced cervical cancer. A company statement says the drug plus concurrent chemoradiotherapy also showed a favorable trend in overall survival, the trial’s other primary endpoint, but those data were not mature at the time of the prespecified interim analysis.

Keytruda currently has two approved cervical cancer indications in the U.S.: in combination with chemotherapy, with or without bevacizumab (Genentech’s Avastin) to treat patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 as determined by an FDA-approved test; and as a single agent to treat patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test.

Keytruda is described as a humanized monoclonal antibody anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor and healthy cells.