KIRKLAND, QC,
Sept. 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, as a
monotherapy for the treatment of adult and pediatric patients with
unresectable or metastatic microsatellite instability-high (MSI-H)
or mismatch repair deficient (dMMR) solid tumours, as determined by
a validated test, that have progressed following prior treatment
and who have no satisfactory alternative treatment options. This
approval is based on the results from Phase II KEYNOTE-158,
KEYNOTE-164, and KEYNOTE-051 trials, and includes data from 504
patients across more than 30 cancer types.
"This news helps reinforce Merck's ongoing commitment to
research and development in immuno-oncology," expressed André
Galarneau, PhD, Executive Director & Vice President, Oncology
Business Unit at Merck Canada. "This is a step forward in
addressing an important unmet medical need for patients with
unresectable or metastatic MSI-H/dMMR solid tumours."
About KEYNOTES-158, 164 and 051
The efficacy of pembrolizumab was investigated in
504 patients with MSI‑H or dMMR cancer enrolled in three
multicenter, nonrandomized, open-label, multi-cohort studies:
KEYNOTE-164 (NCT02460198), KEYNOTE-158 (NCT02628067) and
KEYNOTE-051 (NCT02332668).
- KEYNOTE‑164 enrolled 124 patients with advanced MSI‑H or dMMR
colorectal cancer (CRC) that progressed following treatment with a
fluoropyrimidine and either oxaliplatin or irinotecan +/-
anti‑VEGF/EGFR mAb‑based therapy.
- KEYNOTE‑158 enrolled 373 patients with advanced MSI‑H or dMMR
non-colorectal cancer (non-CRC) who had disease progression
following prior therapy.
- KEYNOTE-051 enrolled 7 pediatric patients with MSI-H or dMMR
cancers.
The major efficacy outcome measures were objective response rate
(ORR) and duration of response (DoR) as assessed by BICR according
to RECIST 1.1 and as assessed by the investigator according to
RECIST 1.1 in KEYNOTE-051.
In a pooled analysis for adult patients, pembrolizumab
demonstrated an ORR of 34% (95% CI, 30,38), including a complete
response rate of 11% and partial response rate of 23%. The median
follow-up time for 497 adult and 7 pediatric patients treated with
pembrolizumab was 20.5 months and 5.2 months respectively. In the
pooled adult patient population (n=497), 75% had responses lasting
36 months or longer with the median DOR of 63.2 months (range, 1.9+
to 63.9+ months).
The most common adverse events (reported in at least 10% of
patients) were pruritus, fatigue, diarrhea, and arthralgia.
For complete information, refer to the KEYTRUDA®
(pembrolizumab) product monograph.
About Microsatellite Instability-High (MSI-H) and Deficient
Mismatch Repair (dMMR) Cancers
In normal cells, a process called mismatch repair (MMR) fixes
errors (such as mutations) that can happen when DNA divides and
makes a copy of itself. If a cell's MMR system isn't working
correctly, errors will build up and cause the DNA to become
unstable. Certain cancer tumours are referred to as having an "MSI
status," meaning they are described as either MSI (microsatellite
instable) or MSS (microsatellite stable). MSI biomarkers indicate
how stable the DNA is in a tumour. Microsatellite instability high
(MSI-H) or mismatch repair deficient (dMMR) are abnormal test
results that indicate a cancer tumour has microsatellite
instability. Microsatellite instability is found most often in
colorectal cancer, gastric cancer, and endometrial cancer, but it
may also be found in many other types of cancer.
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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