Pembrolisabeb, an immune checkpoint inhibitor, has been approved by the US Food and Drug Administration (FDA) for the treatment of patients with advanced head and neck squamous cell carcinoma, whose tumors express PD-L1, whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] As determined by a test approved by the FDA.

FDA Approval Pivotle Keenote-689 study, a random, open-leable phase 3 is based on clinical test data, in which patients receiving pambrolizumbers before and after standard-off-care surgery had prolonged existence without cancer, and high-free tumor narration before surgery. The study was led by investigators at the Dana-Prabar Brigham Cancer Center And Washington University School of Medicine at St. Louis.

It represents adequate changes in the workflow for the new Regimene head and neck cancer, providing suitable patients to obtain pembrolizumb before surgery for locally advanced head and neck cancer.

These findings represent a truly exciting time for our patients, as it is the first advance in this region in two decades. ,

Dr. Ravindra Uppaluri, overall principal investigator of the study, Dana-Prabar and Brigham and Brigham at Women’s Hospital, Director of Head and Neck Surgical Oncology, and Brigham and Women’s Hospital performed the chair in Otolaringology.

Dr. Robert and Chief of Neck Oncology and head of neck oncology and head of neck oncology, Dr. Robert Hadd said, “This is the first approval of a checkpoint inhibitor in the curative, perioperative setting and it represents a large -scale paradigm change of how we surgery leads head and neck cancer.” Keenot -689 Steering Committee.

The Keenote -689 test received 714 patients with the new diagnostic phase 3 or stage 4A head and neck squamous cell cancer randomly obtained the standard of care during and later (called) during and after (called) to receive either pembrolizub. Investigators also measured the presence of a target of pembrolizumbe, PD-L1 in the tumor, to determine whether the PD-L1 in the tumor would affect the reaction to the high score treatment of the PD-L1.

The study showed its primary closing point that patients receiving pembrolizub had prolonged occurrence-free existence. The median event-free survival was 51.8 months with Pembrolizub and 30.4 after an average of 38.3 months follow-up. The team also saw a significant rate of major pathological reactions, which is a sufficient immune arbitration tumor destruction seen in surgical resolution.

Treatment was found safe without any newly seen side effects. In addition, patients taking Pambrolizube received surgery on time and did not delay it. immunotherapy-It side effects before the surgist.

The data was previously presented at the annual meeting of the 2025 American Association of Cancer Research (AACR).