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 8th 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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