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Pembrolizumab, an immune checkpoint inhibitor, has been authorized by the U.S. Meals and Drug Administration (FDA) for the therapy of sufferers with resectable domestically 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 examine, a randomized, open-label section 3 scientific trial by which sufferers who acquired 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 examine was led by investigators from Dana-Farber Brigham Most cancers Heart and Washington College College of Drugs 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 domestically superior head and neck most cancers.
“These findings represent a truly exciting time for our patients, as it is the first advance in this field in over two decades,” stated Dr. Ravindra Uppaluri, the examine’s general principal investigator, director of Head and Neck Surgical Oncology at Dana-Farber and Brigham and Ladies’s Hospital, and Brigham and Ladies’s Hospital Endowed Chair in Otolaryngology.
“This is the first approval of a checkpoint inhibitor in the curative, perioperative setting and it represents a massive paradigm shift in how we manage surgically treated head and neck cancer going forward,” stated 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 medication at Harvard Medical College and the Dana-Farber Brigham Most cancers Heart 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 (referred to as neoadjuvant), throughout and after (referred to as adjuvant) normal of care or normal of care alone. The investigators additionally measured the presence of the goal of pembrolizumab, PD-L1, in tumors to find out if greater scores of PD-L1 in tumors would have an effect on response to therapy.
The examine met its main endpoint displaying that sufferers who acquired 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 workforce additionally noticed considerably greater charges of main pathologic response, a considerable immune mediated tumor destruction seen in surgical resections.
The therapy was discovered to be protected with no new noticed unintended effects. Additional, sufferers taking pembrolizumab acquired surgical procedure in a well timed method and weren’t delayed by immunotherapy-related unintended effects previous to surgical procedure.
The information was beforehand offered on the 2025 American Affiliation of Most cancers Analysis (AACR) Annual Assembly.
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Dana-Farber Most cancers Institute
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FDA approves pembrolizumab for resectable head and neck most cancers with PD-L1 expression (2025, June 14)
retrieved 14 June 2025
from https://medicalxpress.com/information/2025-06-fda-pembrolizumab-resectable-neck-cancer.html
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