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# Merck Halts Keytruda Lung Cancer Trial
- URL: https://www.fdaweb.com/merck-halts-keytruda-lung-cancer-trial/
- Published: 2023-12-07T12:00:00.000Z
- Updated: 2026-09-14T14:17:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155946

Merck has stopped its Phase 3 KEYLYNK-008 trial evaluating anti-PD-1 therapy Keytruda (pembrolizumab) in combination with maintenance Lynparza (AstraZeneca’s PARP inhibitor) for treating patients with metastatic squamous non-small cell lung cancer. The decision was based on a recommendation from an independent data monitoring committee that reviewed data from a planned interim analysis and concluded the combination did not demonstrate an improvement in overall survival compared to Keytruda in combination with chemotherapy followed by Keytruda plus placebo, according to the company. Additionally, the analysis looked at progression-free survival, which was not statistically significant despite a numerical improvement compared to the control arm. Merck says that the safety profile in the trial was consistent with that observed in previously reported studies for the individual therapies, and no new safety signals were identified.

Monoclonal antibody Keytruda works by increasing the immune system’s ability to help detect and fight tumor cells, Merck says. It also blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, “thereby activating T lymphocytes which may affect both tumor cells and healthy cells,” it says.