US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The study evaluated Keytruda as a perioperative treatment.
KEYNOTE-689 is the first Phase III study to demonstrate statistically significant and clinically meaningful improvements in EFS for patients treated with the Keytruda perioperative regimen. Additionally, the study showed a statistically significant improvement in major pathological response (mPR), a key secondary endpoint, for patients receiving Keytruda compared to those on adjuvant radiotherapy alone. The safety profile of Keytruda was consistent with previous studies, with no new safety signals identified.
Keytruda, a humanized monoclonal antibody, works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that target both tumor and healthy cells. With over 1600 clinical trials globally, Keytruda has received more than 40 indication approvals and has gained 14 indications in the US and China respectively. – Flcube.com
