Approval is based on the Phase 3 KEYNOTE-966
Trial
KIRKLAND, QC,
May 9,
2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside
the United States and Canada, announced that Health Canada has
granted approval of KEYTRUDA®
(pembrolizumab), Merck's anti-PD-1 therapy, in
combination with gemcitabine-based chemotherapy, for the treatment
of adult patients with locally advanced unresectable or metastatic
biliary tract carcinoma (BTC). This approval is based on the
results from the Phase 3 KEYNOTE-966 trial, which demonstrated a
statistically significant and clinically meaningful improvement in
overall survival (OS) versus chemotherapy alone.
"Biliary tract cancer is usually diagnosed at an advanced stage,
where patient survival rates are poor," says André Galarneau, PhD,
Executive Director & Vice President, Oncology Business Unit at
Merck Canada. "The addition of this indication shows promising
overall survival results, which means more potential treatment
options for biliary cancer patients in urgent need."
About KEYNOTE-966
KEYNOTE-966 was a multicentre, randomized, double-blind,
placebo-controlled Phase 3 trial (ClinicalTrials.gov NCT04003636)
evaluating pembrolizumab in combination with gemcitabine and
cisplatin compared to placebo plus gemcitabine and cisplatin for
the first-line treatment of advanced and/or unresectable BTC. The
primary endpoint was OS, and the secondary endpoints included
progression-free survival (PFS), objective response rate (ORR), as
assessed by BICR according to RECIST v1.1.
The trial enrolled 1,069 patients with locally advanced
unresectable or metastatic BTC, who had not received prior systemic
therapy in the advanced disease setting. Patients were randomized
(1:1) to receive pembrolizumab (200 mg every three weeks for up to
approximately two years) plus gemcitabine and cisplatin, or placebo
plus gemcitabine and cisplatin. Treatment continued until
unacceptable toxicity or disease progression. For pembrolizumab,
treatment continued for a maximum of 35 cycles, or approximately 24
months. For cisplatin, treatment could be administered for a
maximum of 8 cycles and for gemcitabine, treatment could be
continued beyond 8 cycles.
Pembrolizumab with the gemcitabine/cisplatin arm demonstrated a
clinically meaningful and statistically significant improvement
versus the placebo with gemcitabine/cisplatin arm in OS. In the
study, there was a 17% reduction in the risk of death with
pembrolizumab plus gemcitabine/cisplatin (HR=0.83 [95% CI,
0.72-0.95]; p=0.0034) versus gemcitabine/cisplatin alone. The
median PFS was 6.5 months (95% CI, 5.7-6.9) for the pembrolizumab
plus chemotherapy arm versus 5.6 months (95% CI, 5.1,6.6) for the
placebo plus chemotherapy arm. The objective response rate at the
pre-specified interim analysis was 28.7% (24.9, 32.8) versus 28.5%
(24.8, 32.6) respectively.
The most common treatment-related adverse events (reported in at
least 20% of patients) were neutrophil count decreased, anemia,
platelet count decreased, nausea, fatigue, and white blood cell
count decreased.
For complete information, refer to the KEYTRUDA®
product monograph.
About Biliary Tract
Cancer
Biliary tract cancer is a group of rare and highly aggressive
cancers in the gallbladder and bile ducts. Biliary tract cancer is
the second most common type of primary liver cancer after
hepatocellular carcinoma, accounting for 15% of all liver cancers.
It is estimated there are approximately 211,000 new cases of BTC
diagnosed and 174,000 deaths from the disease each year globally.
Biliary tract cancer is most frequently diagnosed in patients
between 50 to 70 years old, and 60-70% of BTC patients are
diagnosed at an advanced stage. Patients diagnosed with BTC face a
very poor prognosis, as the five-year survival rate is estimated to
be between 5% and 15%.
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.
Forward-Looking Statement of Merck
& Co. Inc., Rahway, NJ,
USA
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"forward-looking statements" within the meaning of the safe harbor
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with respect to pipeline candidates that the candidates will
receive the necessary regulatory approvals or that they will prove
to be commercially successful. If underlying assumptions prove
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may differ materially from those set forth in the forward-looking
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development, including obtaining regulatory approval; the company's
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manufacturing difficulties or delays; financial instability of
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The company undertakes no obligation to publicly update any
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future events or otherwise. Additional factors that could cause
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SEC's Internet site (www.sec.gov).
Please see the product monograph for KEYTRUDA®
(pembrolizumab) at Merck.ca.
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license.
© 2024 Merck & Co., Inc., Rahway,
NJ, USA and its affiliates. All rights reserved.
SOURCE Merck Canada Inc.