Merck (MSD outside the US and Canada) has secured Health Canada approval for Keytruda (pembrolizumab) to treat a type of advanced head and neck cancer.
Keytruda is a humanised monoclonal antibody engineered to enhance the body’s immune response by blocking the interaction between PD-1 and its ligands.
The anti-PD-1 therapy has been indicated now in Canada for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.
It is approved as a neoadjuvant treatment, continued as adjuvant treatment with radiotherapy, with or without cisplatin, and then as monotherapy.
Keytruda was initially approved in Canada in 2015 and is used for various cancers, including melanoma and non-small cell lung carcinoma (NSCLC).
Merck Canada oncology business unit executive director and vice president André Galarneau said: “We know that head and neck squamous cell carcinomas present significant treatment challenges because of their complexity.
“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.”
The latest Health Canada approval is based on positive results from the Phase 3 KEYNOTE-689 trial evaluating pembrolizumab in patients with advanced HNSCC.
In the study, 714 patients were randomised into two treatment arms, with pembrolizumab administered as neoadjuvant therapy followed by adjuvant therapy.
Keytruda plus adjuvant radiotherapy and optionally cisplatin reduced event-free survival risk by 30% compared to radiotherapy with or without cisplatin alone.
Tumour status assessments occurred before surgery, after adjuvant phase initiation, and periodically until the study’s end.
The primary efficacy outcome was event-free survival (EFS), with secondary measures including overall survival (OS).
The pembrolizumab arm showed a median EFS of 59.7 months compared to 29.6 months in the radiotherapy arm.
Common treatment-related adverse events in the study’s pembrolizumab arm include radiation skin injury and stomatitis.
