Merck’s Keytruda Achieves Industry-First Success in Preventing Head and Neck Cancer Recurrence: AACR 2025 Highlights

At AACR 2025, Merck presented results from the KEYNOTE-689 Phase III trial, showing Keytruda (pembrolizumab) significantly improved event-free survival (EFS) compared to standard of care alone in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC)235.

This marks the first major positive clinical trial result for resectable LA-HNSCC patients in over 20 years, representing a significant milestone for this patient population25.

Keytruda as part of a perioperative regimen cut the risk of disease progression or recurrence by 27% in the overall study population versus standard of care therapy alone45.

The survival benefit was even greater (34% reduction in event risk) for patients whose tumors had high PD-L1 expression, according to subgroup analyses4.

Event-free survival in KEYNOTE-689 was defined as the time until radiographic progression, local or distant recurrence, or death from any cause4.

Results were presented during a plenary session and included in the AACR 2025 official press program23.

The FDA is currently reviewing Merck's supplemental Biologics License Application (sBLA) for Keytruda in this indication, with a decision expected by June 23, 20254.

Sources:

2. https://www.merck.com/news/keytruda-pembrolizumab-as-perioperative-treatment-with-standard-of-care-soc-adjuvant-therapy-significantly-improved-event-free-survival-compared-to-soc-alone-in-patients-with-resectable-loca/

3. https://www.aacr.org/about-the-aacr/newsroom/news-releases/adding-perioperative-pembrolizumab-to-standard-of-care-improves-outcomes-in-patients-with-newly-diagnosed-head-and-neck-cancer/

4. https://www.biospace.com/drug-development/perioperative-keytruda-cuts-risk-of-negative-events-by-over-25-in-head-and-neck-cancer

5. https://www.appliedclinicaltrialsonline.com/view/keytruda-survival-hnscc-head-neck-squamous-cell-carcinoma