Pembrolizumab, an immune checkpoint inhibitor, has been permitted by the U.S. Meals and Drug Administration (FDA) for the remedy of sufferers with resectable regionally superior head and neck squamous cell carcinoma whose tumors categorical PD-L1 [Combined Positive Score (CPS) ≥1] as decided by an FDA-approved check.
The FDA approval is predicated on knowledge from the pivotal KEYNOTE-689 research, a randomized, open-label part 3 scientific trial wherein sufferers who obtained pembrolizumab earlier than, throughout and after standard-of-care surgical procedure had longer event-free survival with out the most cancers coming again and better charges of considerable tumor shrinkage previous to surgical procedure. The research was led by investigators from Dana-Farber Brigham Most cancers Middle and Washington College Faculty of Medication in St. Louis.
This new routine represents a considerable change in workflow for head and neck most cancers care, providing applicable sufferers the choice of receiving pembrolizumab earlier than surgical procedure for resectable regionally superior head and neck most cancers.
These findings signify a really thrilling time for our sufferers, as it’s the first advance on this area in over 20 years.”
Dr. Ravindra Uppaluri, research’s total principal investigator, director of Head and Neck Surgical Oncology at Dana-Farber and Brigham and Girls’s Hospital, and Brigham and Girls’s Hospital Endowed Chair in Otolaryngology
“That is the primary approval of a checkpoint inhibitor within the healing, perioperative setting and it represents an enormous paradigm shift in how we handle surgically handled head and neck most cancers going ahead,” mentioned Dr. Robert Haddad, chief of the Division of Head and Neck Oncology and the McGraw Chair in Head and Neck Oncology at Dana-Farber, professor of drugs at Harvard Medical Faculty and the Dana-Farber Brigham Most cancers Middle principal investigator and member of the KEYNOTE-689 steering committee.
The KEYNOTE-689 trial randomized 714 sufferers with newly recognized stage 3 or stage 4A head and neck squamous cell most cancers to obtain both pembrolizumab earlier than (known as neoadjuvant), throughout and after (known as adjuvant) commonplace of care or commonplace of care alone. The investigators additionally measured the presence of the goal of pembrolizumab, PD-L1, in tumors to find out if increased scores of PD-L1 in tumors would have an effect on response to remedy.
The research met its major endpoint displaying that sufferers who obtained pembrolizumab had longer event-free survival. Median event-free survival was 51.8 months with pembrolizumab and 30.4 with out after a median of 38.3 months of follow-up. The crew additionally noticed considerably increased charges of main pathologic response, a considerable immune mediated tumor destruction seen in surgical resections.
The remedy was discovered to be secure with no new noticed unwanted effects. Additional, sufferers taking pembrolizumab obtained surgical procedure in a well timed method and weren’t delayed by immunotherapy-related unwanted effects previous to surgical procedure.
The information was beforehand offered on the 2025 American Affiliation of Most cancers Analysis (AACR) Annual Assembly.