Merck has announced that the Phase 3 KEYNOTE-689 trial for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, has achieved its primary endpoint of event-free survival (EFS) in patients with newly diagnosed, stage III or IVA resected locally advanced head and neck squamous cell carcinoma. The study assessed KEYTRUDA as a neoadjuvant therapy before surgery, followed by adjuvant treatment with radiotherapy and KEYTRUDA, compared to standard-of-care radiotherapy alone. The independent Data Monitoring Committee's interim analysis revealed a statistically significant improvement in EFS and major pathological response for those receiving the KEYTRUDA regimen.
Dr. Marjorie Green, Senior Vice President at Merck, emphasized the trial's significance, stating it marks the first positive trial in two decades for this patient population. While a trend toward improved overall survival was observed, it did not reach statistical significance for patients with PD-L1 Combined Positive Score ≥10. KEYTRUDA is currently approved for various uses, including as monotherapy and in combination therapies for metastatic or unresectable recurrent HNSCC, and the results will be presented at upcoming medical meetings.
