Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 1), as determined by a validated test, as neoadjuvant treatment as monotherapy, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as monotherapy.
The approval is based on data from the Phase 3 KEYNOTE-689 trial, which demonstrated positive clinical outcomes in patients with resectable locally advanced HNSCC whose tumours expressed PD-L1 (CPS ≥ 1). Perioperative KEYTRUDA® in combination with adjuvant radiotherapy with or without cisplatin reduced the risk of event free survival (EFS) by 30% (Hazard Ration [HR]=0.70 [95% Confidence Interval [CI]: 0.55–0.89; p=0.0014]) compared to adjuvant radiotherapy with or without cisplatin.
"We know that head and neck squamous cell carcinomas present significant treatment challenges because of their complexity," said André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "The introduction of a perioperative anti-PD-1 treatment option for eligible patients in Canada represents an important development with the potential to make a meaningful difference for patients and their families impacted by this disease."
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