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FDA Reviews Pembrolizumab for Transformative Head and Neck Cancer Treatment

KEYNOTE-689 trial shows significant survival benefits and tumor response with perioperative immunotherapy, marking the first major advance in over 20 years.

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Overview

  • The KEYNOTE-689 phase 3 trial demonstrated that pembrolizumab before, during, and after surgery extended median event-free survival to 51.8 months compared to 30.4 months with standard care alone.
  • The trial also showed significantly higher rates of major pathologic response, indicating robust tumor destruction prior to surgery.
  • Pembrolizumab was found to be safe, with no new side effects, and did not delay surgical timelines, ensuring compatibility with current treatment workflows.
  • The FDA is actively reviewing pembrolizumab for approval in resectable head and neck squamous cell carcinoma, potentially establishing it as a new standard of care.
  • Experts emphasize the need for multidisciplinary care to integrate this immunotherapy approach, which represents a paradigm shift in managing locally advanced head and neck cancer.