MSD (MRK.US)'s pabolizumab approved as HNSCC's first perioperative treatment

The Zhitong Finance App learned that on June 12, the FDA's official website showed that pabolizumab (K drug) of MSD (MRK.US) was approved as a new indication for new adjuvant treatment (single drug, 2 cycles) and adjuvant treatment (first combined radiotherapy ± cisplatin, 3 cycles, then single drug, 12 cycles) tumors expressing PD-L1 CPS≥1 resectable locally advanced head and neck squamous cell carcinoma (HNSCC). According to the FDA, this is the first new drug approved in the field of HNSCC in 6 years, and the first drug approved for the perioperative treatment of locally advanced HNSCC.

This approval is based on the positive results of the Phase III KEYNOTE-689 study. The study was a randomized, multicenter, open-label trial (n=714) to evaluate the efficacy and safety of pabolizumab perioperative treatment in patients with locally resectable advanced (stage III-IVA) HNSCC. Patients in the control group did not receive new adjuvant treatment before surgery, and only received radiotherapy ± cisplatin as adjuvant treatment after surgery. In both treatment groups, patients with high-risk pathological features during surgery (i.e., positive incision <1 mm or extranodal extension) need cisplatin combined with radiotherapy as adjuvant treatment.

Currently, only 5 targeted drugs have been approved for the treatment of HNSCC worldwide, including pabolizumab, navulimab, cetuximab saratolacan, cetuximab, and finolizumab.