Approval is based on the Phase 3 KEYNOTE-811
Trial
KIRKLAND, QC, Feb. 12,
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 trastuzumab, fluoropyrimidine- and
platinum-containing chemotherapy, for the first-line treatment of
adult patients with locally advanced unresectable or metastatic
HER2 positive gastric or gastroesophageal junction (GEJ)
adenocarcinoma whose tumours express PD-L1 (Combined Positive Score
[CPS] ≥ 1) as determined by a validated test. This approval is
based on the results from the Phase 3 KEYNOTE-811 trial, which
demonstrated a statistically significant improvement in
progression-free survival (PFS) compared to placebo in combination
with trastuzumab and chemotherapy in the intention-to-treat (ITT)
study population.
"The approval granted by Health Canada represents a significant
milestone for patients with advanced gastric and GEJ adenocarcinoma
- cancer types in which patients have faced limited treatment
options," says André Galarneau, PhD, Executive Director & Vice
President, Oncology Business Unit at Merck Canada. "Our commitment
to delivering more options to patients and their families is
underscored by the results observed in this Phase 3 trial,
representing a step forward in our mission to bring more hope to
Canadians impacted by this challenging disease."
About KEYNOTE-811
KEYNOTE-811 was a randomized, double-blind Phase 3 trial
(ClinicalTrials.gov, NCT03615326) evaluating pembrolizumab in
combination with trastuzumab and chemotherapy for the first-line
treatment of locally advanced unresectable or metastatic
HER2-positive gastric or GEJ adenocarcinoma. The dual primary
endpoints were PFS per RECIST v1.1 as assessed by blinded
independent central review and overall survival (OS). Secondary
endpoints included objective response rate (ORR), duration of
response (DOR) and safety. The trial enrolled 698 patients who were
randomized to receive pembrolizumab (200 mg every three weeks) in
combination with trastuzumab, fluoropyrimidine- and
platinum-containing chemotherapy (investigator's choice of
5-fluorouracil plus cisplatin or capecitabine plus oxaliplatin), or
placebo in combination with trastuzumab and chemotherapy. Among the
698 patients randomized in KEYNOTE-811, 594 (85%) had tumors that
expressed PD-L1 with a CPS ≥1.
At the first interim analysis conducted on the first 264
patients randomized in the overall population (133 patients in the
pembrolizumab arm and 131 in the placebo arm), a statistically
significant improvement was observed in the ORR (74.4% vs 51.9%,
representing a 22.7% difference; 95% CI (11.2, 33.7); p-Value
0.00006).
At the second interim analysis in the overall population, a
statistically significant improvement in PFS (HR 0.72; 95% CI 0.60,
0.87; p-Value 0.0002) was demonstrated in patients randomized to
pembrolizumab in combination with trastuzumab and chemotherapy
compared with placebo in combination with trastuzumab and
chemotherapy. At the time of this analysis in the overall
population, there was no statistically significant difference with
respect to OS.
The most frequently reported treatment-related adverse events
(≥20% incidence) for pembrolizumab in combination with trastuzumab,
fluoropyrimidine- and platinum-containing chemotherapy group were
diarrhea, nausea, anemia, neutrophil count decreased, decreased
appetite, platelet count decreased, vomiting, peripheral sensory
neuropathy, and palmar-plantar erythrodysesthesia syndrome.
For complete information, refer to the product monograph:
https://www.merck.ca/en/keytruda-pm_e.
About Gastric Cancer
Gastric (stomach) cancer tends to develop slowly over many years
and rarely causes symptoms in its early stages, resulting in
nearly half of cases being diagnosed at an advanced stage. About
95% of gastric cancers are adenocarcinomas, which develop from
cells in the innermost lining of the stomach, known as the mucosa.
In 20-25% of patients with GEJ/gastric adenocarcinoma, there is
tumour over-expression of the HER2 protein. It was estimated that
gastric cancer accounted for approximately 4,100 cases and 2,000
deaths in Canada in 2023, with the
highest mortality rates in Newfoundland and Labrador. Based on statistics from
the United States, the relative
five-year survival for patients diagnosed with gastric cancer at an
advanced stage (cancer that had spread to other parts of the body)
is only 5%.
About
KEYTRUDA®
KEYTRUDA® is an anti-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
This news release of Merck & Co., Inc., Rahway, N.J., USA (the "company") includes
"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
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inaccurate or risks or uncertainties materialize, actual results
may differ materially from those set forth in the forward-looking
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The company undertakes no obligation to publicly update any
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Please see the product monograph for KEYTRUDA®
(pembrolizumab) at:
https://www.merck.ca/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf
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SOURCE Merck Canada Inc.