American pharma giant Merck’s application for KEYTRUDA® (pembrolizumab) receives US FDA’s priority review acceptance. Acceptance based on results from the KEYNOTE-689 trial. This is the first Phase 3 study to show a notable increase in event-free survival in the early stages of head and neck squamous cell carcinoma when using an anti-PD-1 treatment in a neoadjuvant and adjuvant scenario.
In order to approve Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), the FDA has accepted a new supplemental Biologics License Application (sBLA) for priority review. The sBLA will first be used as a neoadjuvant treatment, followed by adjuvant treatment in combination with standard-of-care radiation therapy with or without cisplatin, and finally as a single agent.
Data from the Phase 3 KEYNOTE-689 trial served as the basis for the sBLA. In patients with resectable LA-HNSCC, the KEYTRUDA perioperative treatment regimen showed a statistically significant and clinically meaningful improvement in event-free survival (EFS) compared to adjuvant radiotherapy (with or without cisplatin) alone, according to results from a pre-specified first interim analysis that will be presented at a future medical meeting. Comparing patients in the KEYTRUDA arm to those receiving adjuvant radiation alone, the trial also revealed a statistically significant improvement in major pathological response (mPR), a crucial secondary goal. No new safety signals were found, and KEYTRUDA’s safety profile was in line with that seen in earlier research.
Also Read: Pembrolizumab, an immunotherapy medication, improves outcomes for patients with soft tissue sarcoma
The standard of care for patients with resectable locally advanced head and neck squamous cell carcinoma has remained the same for over two decades, representing a significant unmet need for new treatment options,
Based on the compelling results of the KEYNOTE-689 trial, we hope to reduce the risk of recurrence and disease progression in earlier stages of disease. We look forward to working with the FDA to potentially bring KEYTRUDA to these patients as soon as possible.
Dr. Marjorie Green
Also Read: US FDA Approves Ctexli, First Treatment for Cerebrotendinous Xanthomatosis of Mirum Pharma
The FDA Oncology Center of Excellence’s Project Orbis initiative, which offers a framework for coordinated submission and assessment of oncology medications among its international partners, is the vehicle for this study. Under Project Orbis, this proposal will be reviewed by health authorities in Israel, Canada, Australia, Singapore, Brazil, and Switzerland.
For suitable patients with metastatic or unresectable, recurrent HNSCC, KEYTRUDA® is now licensed as monotherapy and in combination regimens in the United States, Europe, China, Japan, and other nations.
Last Modified:
