Merck’s KEYNOTE-689: Major Success in Cancer Treatment

Merck has announced positive results from its Phase 3 KEYNOTE-689 trial, which evaluated KEYTRUDA® (pembrolizumab) as a perioperative treatment for patients with stage III or IVA resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The trial met its primary endpoint by significantly improving event-free survival (EFS) when KEYTRUDA was used as neoadjuvant therapy before surgery, followed by adjuvant therapy with radiotherapy (with or without cisplatin) and continued maintenance. The trial also showed significant improvement in major pathological response (mPR) compared to radiotherapy alone.

Although there was a trend toward improved overall survival (OS), it did not reach statistical significance at this point in the trial. The study’s safety profile was consistent with previous findings, with no new safety concerns identified. These results, the first major positive findings in two decades for this patient group, could be practice-changing and further highlight KEYTRUDA’s role in treating earlier-stage LA-HNSCC.

Further analysis of overall survival will be conducted at the next interim review, and results will be presented at an upcoming medical meeting. KEYTRUDA is already approved in various regions, including the U.S., Europe, and China, for advanced head and neck cancers.