Health Canada Approves Merck's KEYTRUDA® (pembrolizumab) for the treatment of adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery

Approval is based on the Phase 3 KEYNOTE-671 Trial

KIRKLAND, QC, Feb. 11, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that Health Canada has granted approval for KEYTRUDA^® (pembrolizumab), Merck's anti-PD-1 therapy, as a treatment for adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. This approval is based on results from the Phase 3 KEYNOTE-671 trial, which demonstrated statistically significant results for its dual primary endpoints of event-free survival (EFS) and overall survival (OS) versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone.   

"While we have made significant advancements for patients with advanced lung cancer, it remains the leading cause of cancer-related deaths in Canada. This underscores the importance of addressing lung cancer cases in earlier stages, to help improve patient outcomes," stated Dr. Jonathan Spicer, thoracic surgeon and scientist at the McGill University Health Centre (MUHC), Scientist in the Cancer Research Program at The Institute, Professor of Surgery at McGill University, and Medical Director of the McGill Thoracic Oncology Network. "This recent approval adds another therapeutic option for patients with operable non-small cell lung cancer."

"Today, we've made a significant step forward with the approval of the first anti-PD-1 therapy in Canada for the perioperative treatment of resectable non-small cell lung cancer. This approval highlights our commitment to expanding treatment options for lung cancer patients," expressed André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. "We're excited to continue this progress and collaborate with community partners to help patients affected by this disease."

About KEYNOTE-671
KEYNOTE-671 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT03425643) evaluating KEYTRUDA^® in combination with platinum-containing chemotherapy given as neoadjuvant treatment and continued as monotherapy adjuvant treatment, versus placebo plus neoadjuvant chemotherapy, followed by resection and adjuvant placebo. Patients with previously untreated and resectable Stage II, IIIA, or IIIB (N2) NSCLC as assessed by the AJCC 8^th edition were eligible for the trial. Patients were enrolled regardless of tumour PD-L1 expression. Patients with active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, a history of interstitial lung disease (ILD)/pneumonitis that required steroid treatment were ineligible. Randomization was stratified by stage (II vs. III), tumour PD-L1 expression (TPS ≥50% or <50%), histology (squamous vs. non squamous), and geographic region (East Asia vs. non-East Asia). Patients were randomized (1:1) to one of the following treatment arms: 

• Treatment Arm A: neoadjuvant KEYTRUDA^® 200 mg on Day 1 in combination with cisplatin 75 mg/m² and either pemetrexed 500 mg/m² on Day 1 or gemcitabine 1000 mg/m² on Days 1 and 8 of each 21-day cycle for up to 4 cycles. Following surgery, KEYTRUDA^® 200 mg was administered every 3 weeks for up to 13 cycles.
• Treatment Arm B: neoadjuvant placebo on Day 1 in combination with cisplatin 75 mg/m2 and either pemetrexed 500 mg/m2 on Day 1 or gemcitabine 1000 mg/m2 on Days 1 and 8 of each 21-day cycle for up to 4 cycles. Following surgery, placebo was administered every 3 weeks for up to 13 cycles.

The dual primary efficacy outcome measures were investigator-assessed event-free survival (EFS) and overall survival (OS). Secondary efficacy outcome measures included pathological complete response (pCR) rate and major pathological response (mPR) rate as assessed by blinded independent pathology review (BIPR). The trial was not designed to isolate the efficacy of KEYTRUDA^® in each phase (neoadjuvant or adjuvant) of treatment.

The trial demonstrated statistically significant improvements in EFS and OS for patients randomized to KEYTRUDA^® in combination with platinum-containing chemotherapy followed by KEYTRUDA^® monotherapy compared with patients randomized to placebo in combination with platinum-containing chemotherapy followed by placebo alone. At the first interim analysis, EFS efficacy results achieved statistical significance with a median follow-up time of 21.4 months (range: 0.4 to 50.6 months). At the second interim analysis, OS efficacy results achieved statistical significance with a median follow-up time of 29.8 months (range: 0.4 to 62.0 months).

For complete information, refer to the KEYTRUDA^® product monograph.

About lung cancer in Canada 
Lung cancer is the leading cause of cancer deaths in Canada. In 2024 alone, estimations indicated that there were approximately 32,100 new cases and over 20,000 deaths from lung cancer. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80-85% of all cases. In recent decades, the overall five-year survival rate for patients diagnosed with lung cancer is on average 22% compared to nearly 90% for other commonly diagnosed cancers such as breast and prostate.

About KEYTRUDA^®
KEYTRUDA^® is an anti-programmed death receptor-1 (PD-1) therapy that works by helping increase the ability of the body's immune system to help detect and fight tumour cells. KEYTRUDA^® is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells.

KEYTRUDA^® was first approved in Canada in 2015 and currently has indications in several disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung carcinoma, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial carcinoma, cervical cancer, esophageal cancer, triple-negative breast cancer, melanoma, and head and neck squamous cell carcinoma.

About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada, visit www.merck.ca and connect with us on LinkedIn and X @MerckCanada.

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^® Merck Sharp & Dohme LLC. Used under license.
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