The article from Business Wire discusses the results of Merck’s Phase 3 KEYNOTE-689 trial, which evaluated the use of KEYTRUDA (pembrolizumab) as a perioperative treatment regimen for patients with resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This trial is significant in demonstrating the efficacy of KEYTRUDA, showing that the treatment can lead to improved patient outcomes. Here are the key points from the study:

Primary Endpoint

The trial met its primary endpoint of event-free survival (EFS), demonstrating a statistically significant and clinically meaningful improvement in EFS for patients receiving the KEYTRUDA regimen compared to those receiving standard adjuvant radiotherapy (with or without cisplatin) alone.

Treatment Regimen

The KEYTRUDA regimen involved neoadjuvant therapy (before surgery) followed by adjuvant therapy (after surgery) in combination with standard-of-care radiotherapy (with or without cisplatin), and then maintenance therapy with KEYTRUDA.

Secondary Endpoints

In addition to the primary endpoint, the study also showed a statistically significant improvement in major pathological response (mPR), a key secondary endpoint, for patients in the KEYTRUDA arm compared to those receiving adjuvant radiotherapy alone.

Safety Profile

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies, with no new safety signals identified, ensuring the treatment regimen remains a viable option.

Clinical Significance

This trial marks the first positive results in two decades for patients with resected, locally advanced head and neck squamous cell carcinoma, highlighting a potential new standard of care for this patient population.

Study Design

KEYNOTE-689 is a randomized, active-controlled, open-label Phase 3 trial that enrolled approximately 704 patients who were randomized 1:1 to receive either the KEYTRUDA regimen or standard adjuvant radiotherapy (with or without cisplatin).

Efficacy Outcomes

The researchers classified efficacy outcomes by PD-L1 Combined Positive Score (CPS) status, although the article does not provide detailed efficacy data stratified by PD-L1 expression levels.

Overall, the KEYNOTE-689 trial demonstrates the efficacy of KEYTRUDA as part of a perioperative treatment regimen for patients with resected, locally advanced head and neck squamous cell carcinoma, offering a promising treatment option for this patient population. The results of the study may change how we approach treatment protocols for LA-HNSCC, emphasizing the new potential of the KEYTRUDA regimen in clinical practice.