Merck's KEYTRUDA Approved for Locally Advanced HNSCC Patients in Canada

Health Canada has approved KEYTRUDA (pembrolizumab) for treating adult patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥ 1). The approval is based on data from the KEYNOTE-689 Phase III clinical trial, which demonstrated positive clinical outcomes in patients with resectable locally advanced HNSCC whose tumors expressed PD-L1 (CPS ≥ 1). KEYTRUDA reduced the risk of event-free survival by 30% compared to adjuvant radiotherapy with or without cisplatin.

Health Canada has granted approval for KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck (NYSE: MRK), for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 1). The approval is based on data from the KEYNOTE-689 Phase III clinical trial, which demonstrated positive clinical outcomes in patients with resectable locally advanced HNSCC whose tumors expressed PD-L1 (CPS ≥ 1).

The KEYNOTE-689 trial randomized 714 patients into two treatment arms. One group received neoadjuvant pembrolizumab 200 mg for 2 cycles every 3 weeks prior to surgical resection, followed by adjuvant treatment with pembrolizumab in combination with either radiation ± cisplatin. The other group received adjuvant radiotherapy ± cisplatin without neoadjuvant treatment. The primary efficacy outcome was event-free survival (EFS), which was reduced by 30% (Hazard Ratio [HR]=0.70 [95% Confidence Interval [CI]: 0.55–0.89; p=0.0014]) in the pembrolizumab arm compared to the RT +/- cisplatin arm.

"This approval represents an important development for patients and their families impacted by head and neck squamous cell carcinoma," 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 is a significant step forward in the fight against this disease."

The approval of KEYTRUDA® for this indication expands the treatment options available for patients with HNSCC, potentially improving outcomes and quality of life. Merck continues to invest in research and development to advance the prevention and treatment of diseases, fostering a diverse and inclusive global workforce to enable a safe, sustainable, and healthy future for all people and communities.

References:
[1] https://www.marketscreener.com/news/health-canada-approves-keytruda-for-patients-with-resectable-locally-advanced-head-neck-squamous-ce7c51dbdc88f12d
[2] https://www.newswire.ca/news-releases/health-canada-approves-keytruda-r-for-patients-with-resectable-locally-advanced-head-amp-neck-squamous-cell-carcinoma-tumours-that-are-pd-l1-cps-positive-as-neoadjuvant-treatment-continued-as-adjuvant-treatment-combined-with-radiotherapy-wi-817696791.html