Conditional Approval Based on Data from Phase
3 KEYNOTE-355 Trial; Introduces First Breast Cancer Indication for
KEYTRUDA®
KIRKLAND, QC, Nov. 23, 2021 /CNW/ - Merck (NYSE: MRK), known as
MSD outside the United States and
Canada, today announced that
Health Canada has granted conditional approval for
KEYTRUDA® (pembrolizumab), Merck's anti-PD-1
therapy, in combination with chemotherapy for the treatment of
locally recurrent unresectable or metastatic triple-negative breast
cancer (TNBC) in adults whose tumors express PD-L1 (Combined
Positive Score [CPS] ≥10) and who have not received prior
chemotherapy for metastatic disease.1 This conditional
approval is based on the results of the pivotal Phase 3 KEYNOTE-355
trial which demonstrated KEYTRUDA®'s ability to improve
progression-free survival (PFS) in combination with chemotherapy
(nab-paclitaxel, paclitaxel or gemcitabine/carboplatin), as
compared to chemotherapy alone.2
"As a complex and challenging subtype of cancer to treat, this
approval is a welcome development for Canadian patients with
triple-negative breast cancer," said Dr. David Cescon, Clinician Scientist, Princess
Margaret Cancer Centre. "About 10-20% of breast cancers are
triple-negative breast cancers. Historically, chemotherapy has been
the main treatment for this type of breast cancer, and there has
been great interest in finding other therapies to help improve
patient outcomes. This news means that there will be more options
available and thus represents an important advance in the treatment
of triple negative-breast cancer."
Breast cancer is one of the most common cancers among Canadian
women and the second leading cause of death from cancer in Canadian
women.3 In 2021, over 27,000 Canadians were
estimated to be diagnosed.3 TNBC is an aggressive
subtype of breast cancer which lacks estrogen receptors,
progesterone receptors and HER2 amplification, making it difficult
to target therapeutically.4 While TNBC can have the same
signs and symptoms as other common types of breast
cancer,5 it differs from other types of invasive breast
cancer in that it grows and spreads quickly, is more likely to have
spread at the time it's found and has fewer treatment options
compared to other types of invasive breast
cancer. 6
"When we hear from people in the metastatic breast cancer
community, they say they want more tools in the toolbox – more
options to help them treat their disease. And while there have been
some advances in targeted treatment in breast cancer, fewer of them
have been intended for people with the triple-negative diagnosis,"
said MJ DeCoteau, Founder and Executive Director, Rethink Breast
Cancer. "New treatment options have been anticipated by patients
and physicians alike for some time."
"It can be devastating to receive a triple-negative breast
cancer diagnosis," said Cathy
Ammendolea, Chair of the Board, Canadian Breast Cancer
Network. "It can be worrying for patients to learn about the
aggressive nature of the disease and the limited treatment options
available to them, but this news can bring some hope to patients
and their families who are on this journey."
About KEYNOTE-355 Trial
Health Canada's approval is
based on findings from the Phase 3 study KEYNOTE-355, a
randomized, double blind, multicenter, placebo-controlled study,
which enrolled 847 patients.7 The key eligibility
criteria for this study were locally recurrent unresectable or
metastatic TNBC, regardless of tumor PD-L1 expression, and which
had not been previously treated with chemotherapy in the metastatic
setting.8
The results of KEYNOTE-355 showed that KEYTRUDA® in
combination with chemotherapy demonstrated a statistically
significant improvement in progression free survival (PFS) compared
to patients treated with placebo in combination with
chemotherapy.9
"As the first indication in breast cancer for
KEYTRUDA®, this approval reinforces our dedication to
patients and our legacy in innovative oncology medicines," said
Marwan Akar, President and Managing
Director, Merck Canada. "We are so proud to expand on our
commitment to discover, develop and provide innovative therapeutic
options to those who need it most."
About Triple-Negative Breast Cancer
TNBC is an
aggressive subtype of breast cancer which lacks estrogen receptors,
progesterone receptors and HER2 amplification, making it difficult
to target therapeutically.4 TNBC has the highest
rates of metastatic disease and the poorest overall survival of all
breast cancer subtypes.4 It
characteristically has a high recurrence rate within the first five
years after diagnosis,6 and tends to be
more common in women under the age of 40.6
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.10 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.11
KEYTRUDA® was first approved in Canada in 2015 and currently has 20
indications in several disease areas, including advanced renal cell
carcinoma (RCC), bladder cancer, non-small cell lung carcinoma
(NSCLC), classical Hodgkin lymphoma (cHL), melanoma and head and
neck squamous cell carcinoma (HNSCC).12
Merck's Research Program
Merck has the industry's
largest immuno-oncology clinical research program. There are
currently more than 750 trials studying pembrolizumab across a
wide variety of cancers and treatment settings. This clinical
program seeks to understand the role of pembrolizumab across
cancers and the factors that may predict a patient's likelihood of
benefitting from treatment with this medication, including
exploring several different biomarkers.
Our Focus on Cancer
Our goal is to translate
progressive science into innovative oncology medicines to help
people with cancer worldwide. At Merck Oncology, helping people
fight cancer is our passion and supporting accessibility to our
cancer medicines is our commitment. Our focus is on pursuing
research in immuno-oncology and we are accelerating every step in
the journey — from lab to clinic — to potentially bring new hope to
people with cancer.
About Merck
For more than 130 years, Merck, known as
MSD outside of the United States
and Canada, has been inventing for
life, bringing forward medicines and vaccines for many of the
world's most challenging diseases in pursuit of our mission to save
and improve lives. We demonstrate our commitment to patients and
population health by increasing access to health care through
far-reaching policies, programs and partnerships. Today, Merck
continues to be at the forefront of research to prevent and treat
diseases that threaten people and animals – including cancer,
infectious diseases such as HIV and Ebola, and emerging animal
diseases – as we aspire to be the premier research-intensive
biopharmaceutical company in the world. For more information
about our operations in Canada,
visit www.merck.ca and connect with us on YouTube and Twitter.
Forward-Looking Statement of Merck & Co. Inc.,
Kenilworth, NJ, USA
This
news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes
"forward-looking statements" within the meaning of the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995. These statements are based upon the current beliefs and
expectations of the company's management and are subject to
significant risks and uncertainties. There can be no guarantees
with respect to pipeline products that the products will receive
the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate
or risks or uncertainties materialize, actual results may differ
materially from those set forth in the forward-looking
statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United
States and internationally; global trends toward health care
cost containment; technological advances, new products and patents
attained by competitors; challenges inherent in new product
development, including obtaining regulatory approval; the company's
ability to accurately predict future market conditions;
manufacturing difficulties or delays; financial instability of
international economies and sovereign risk; dependence on the
effectiveness of the company's patents and other protections for
innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company's 2020
Annual Report on Form 10-K and the company's other filings with the
Securities and Exchange Commission (SEC) available at the SEC's
Internet site (www.sec.gov).
Please see the product monograph for
KEYTRUDA® (pembrolizumab) at:
https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf.
References
______________________________
|
1 KEYTRUDA® Product
Monograph. Merck & Co. Inc. Updated November 19,
2021.
|
2 KEYTRUDA® Product
Monograph. Merck & Co. Inc. Updated November 19,
2021.
|
3 Canadian
Cancer Society. Breast Cancer Statistics. Taken from:
https://cancer.ca/en/cancer-information/cancer-types/breast/statistics.
Accessed October 21, 2021.
|
4 Lee A,
Djamgoz MBA. Triple negative breast cancer: Emerging therapeutic
modalities and novel combination therapies. Cancer Treat Rev. 2018
Jan;62:110-122. doi: 10.1016/j.ctrv.2017.11.003. Epub 2017 Nov 13.
PMID: 29202431.
|
5 American Cancer Society.
Triple-negative breast cancer. Taken from:
https://www.cancer.org/cancer/breast-cancer/about/types-of-breast-cancer/triple-negative.html.
Accessed October 21, 2021.
|
6 Canadian
Cancer Society. Triple-negative and basal like breast
cancers. Taken from:
https://cancer.ca/en/cancer-information/cancer-types/breast/what-is-breast-cancer/cancerous-tumours/triple-negative-breast-cancer.
Accessed October 21, 2021.
|
7 KEYTRUDA® Product
Monograph. Merck & Co. Inc. Updated November 19,
2021.
|
8 KEYTRUDA® Product
Monograph. Merck & Co. Inc. Updated November 19,
2021.
|
9
KEYTRUDA® Product Monograph. Merck & Co. Inc.
Updated November 19, 2021.
|
10 KEYTRUDA® Product
Monograph. Merck & Co. Inc. Updated November 19,
2021.
|
11 KEYTRUDA® Product
Monograph. Merck & Co. Inc. Updated November 19,
2021.
|
12 KEYTRUDA® Product
Monograph. Merck & Co. Inc. Updated November 19,
2021.
|
SOURCE Merck Canada