Merck's Pembrolizumab Receives FDA Approval as First Perioperative Therapy for Locally Advanced HNSCC

Intelligent Finance APP learned on June 12 that the FDA's official website showed that Merck & Co., Inc.'s (MRK.US) pembrolizumab (Keytruda, K drug) was approved for a new indication. It is used for neoadjuvant treatment (monotherapy, 2 cycles) and adjuvant treatment (first combined with radiotherapy ± cisplatin, 3 cycles, then monotherapy, 12 cycles) in tumors expressing PD-L1 CPS≥1 resectable locally advanced head and neck squamous cell carcinoma (HNSCC). The FDA stated that this is the first new drug approval in the HNSCC field in six years and also the first drug approved for perioperative treatment of locally advanced HNSCC.

This approval was based on the positive results of the Phase III KEYNOTE-689 study. The study was a randomized, multicenter, open-label trial (n=714) that evaluated the efficacy and safety of perioperative pembrolizumab in patients with resectable locally advanced (Stage III-IVA) HNSCC. Patients in the control group did not receive neoadjuvant therapy before surgery and only received radiotherapy ± cisplatin as adjuvant treatment post-surgery. In both treatment groups, if patients exhibited high-risk pathological features at the time of surgery (i.e., positive margins <1mm or extranodal extension), they were required to receive cisplatin combined with radiotherapy as adjuvant treatment.

Currently, only five targeted drugs have been approved globally for the treatment of HNSCC, including pembrolizumab, nivolumab, cetuximab saratolacan, cetuximab, and finolimab.