Approval Based on Results of KEYNOTE-426,
Where KEYTRUDA® in Combination with Axitinib Reduced the
Risk of Death by Nearly Half Compared to Sunitinib
- Renal cell carcinoma (RCC) is the most common form of kidney
cancer, representing 80 per cent of all cases1
- The five-year survival rate for advanced RCC is currently
estimated to be 8 per cent2
KIRKLAND, QC, Jan. 23, 2020 /CNW/ - Merck (NYSE: MRK),
known as MSD outside the United
States and Canada, today
announced that Health Canada has approved KEYTRUDA®
(pembrolizumab), Merck's anti-PD-1 therapy, in combination
with Inlyta® (axitinib), a tyrosine kinase inhibitor,
for first-line treatment of patients with advanced renal cell
carcinoma (RCC). The approval is based on findings from the pivotal
Phase 3 KEYNOTE-426 trial, which demonstrated significant
improvements in overall survival (OS), progression-free survival
(PFS) and objective response rate (ORR) for
KEYTRUDA® in combination with axitinib
(KEYTRUDA®-axitinib combination) compared to
sunitinib.
For Canadians living with advanced renal cell carcinoma, the
cancer has spread beyond the kidney to other areas of the
body.3 While the five-year survival rate for patients
living with Stage 1 RCC is currently estimated to be 81 per cent,
those living with advanced (Stage 4) RCC face an 8 per cent chance
of survival.4
"It's important that Canadians living with renal cell carcinoma,
an aggressive form of cancer, have access to new treatment options
that are well tolerated and can improve survival outcomes," said
Dr. Sebastien Hotte, medical
oncologist at McMaster University. "The
approval of pembrolizumab, or KEYTRUDA®, in combination
with axitinib, is an important advancement in treatment that
physicians can now consider in managing patients newly diagnosed
with advanced RCC."
"For kidney cancer patients whose cancer has spread beyond the
kidney and metastasized in other parts of the body, their disease
is much more aggressive. For these patients, there is a need for
additional treatment options," Dr. Pierre Karakiewicz, medical
oncologist at the Centre hospitalier de l'Université de Montréal
(CHUM). "Health Canada's approval
of pembrolizumab in combination with axitinib represents an
important advancement in the treatment of kidney cancer that helps
extend survival outcomes for patients living with advanced renal
cell carcinoma."
In the Phase 3 KEYNOTE-426 trial, KEYTRUDA® in
combination with axitinib demonstrated a statistically
significant reduced risk of death by 47% compared to sunitinib
(HR=0.53 [95% CI, 0.38-0.74]; p=0.00005). For progression-free
survival (PFS), the KEYTRUDA®-axitinib combination
showed a reduction in the risk of progression of disease or death
of 31% compared to sunitinib (HR=0.69 [95% CI, 0.57-0.84];
p=0.00012). The objective response rate (ORR), an additional
efficacy outcome measure, was 59% for patients who received the
KEYTRUDA®-axitinib combination (95% CI, 54-64) and 36%
for those who received sunitinib (95% CI, 31-40) (p<0.0001). The
observed safety profiles of pembrolizumab plus axitinib were as
expected on the basis of the known profiles of these drugs,
although the incidence of grade 3 or 4 elevations in liver enzyme
levels in the pembrolizumab-axitinib group was higher than
previously observed when each agent was used as
monotherapy.5
This is the first indication for KEYTRUDA® in
advanced RCC, and the first anti-PD-1 therapy as part of a
combination regimen that significantly improved OS, PFS and ORR
versus sunitinib in patients with advanced RCC.
"We welcome Health Canada's decision to offer a new
evidence-based treatment option to patients living with advanced
renal cell carcinoma," said Stephen
Andrew, Executive Director of Kidney Cancer Canada. "This
immuno-oncology combination represents an important milestone in
our community and offers new hope to patients and their
caregivers."
About Kidney Cancer
In most cases, kidney cancer
starts in the cells that line the tubules, which are tiny tubes
that collect the waste materials and chemicals from the blood
moving through the kidneys.6 This type of cancer is
known as renal cell carcinoma (RCC), accounting for 80 per cent of
all cases.7 RCC is considered advanced when the cancer
has metastasized, or spread, beyond the primary cancer
site.8 The five-year relative survival rate for patients
suffering from advanced, metastatic (Stage 4) kidney cancer is
estimated to be 8 per cent.9
In 2019, an estimated 7,200 Canadians were diagnosed with kidney
cancer and 1,900 Canadians died from kidney cancer.10
Known risk factors for kidney cancer include smoking, hypertension,
obesity, and occupational exposure to some
chemicals.11
About KEYTRUDA®
KEYTRUDA® is an
anti-PD-1 therapy that works by increasing 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 14
indications in several disease areas, including advanced renal cell
carcinoma (RCC), bladder cancer, non-small cell lung carcinoma
(NSCLC), classical Hodgkin lymphoma and melanoma.
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
breakthrough 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 Canada
For over a century, Merck, a
leading global biopharmaceutical company 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. Through our prescription medicines, vaccines,
biologic therapies and animal health products, we work with
customers and operate in more than 140 countries to deliver
innovative health solutions. We also demonstrate our commitment to
increasing access to health care through far-reaching policies,
programs and partnerships.
Today, Merck continues to be at the forefront of research to
advance the prevention and treatment of diseases that threaten
people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer's
disease and infectious diseases including HIV and Ebola. 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. 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 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 2017
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).
Rini KN-426, NEJM 2019;380:1116-27.
Please see the product monograph for
KEYTRUDA® (pembrolizumab) at:
https://www.merck.ca/static/pdf/KEYTRUDA-PM_E.pdf
References
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___________________________
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1
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De P., Otterstatter,
M.C., Semenciw, R., et al. Trends in incidence, mortality, and
survival for kidney cancer in Canada, 1986-2007. Cancer Causes
Control 2014;25(10):1271-1281.
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2
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Canadian Cancer
Society. Survival statistics for kidney cancer. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/prognosis-and-survival/survival-statistics/?region=on.
Accessed on October 8, 2019.
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3
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Canadian Cancer
Society. Cancerous tumours of the kidney. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/kidney-cancer/cancerous-tumours/?region=on. Accessed
on January 22, 2020.
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4
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Canadian Cancer
Society. Survival statistics for kidney cancer. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/prognosis-and-survival/survival-statistics/?region=on.
Accessed on October 8, 2019.
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5
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Rini B. I,
Plimack E.R, Stus V, et al. Pembrolizumab plus Axitinib versus
Sunitinib for Advanced Renal-Cell Carcinoma. NEJM
2019;380:1116-27.
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6
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Canadian Cancer
Society. What is kidney cancer? Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/kidney-cancer/?region=on.
Accessed on October 9, 2019.
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7
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De P., Otterstatter,
M.C., Semenciw, R., et al. Trends in incidence, mortality, and
survival for kidney cancer in Canada, 1986-2007. Cancer Causes
Control 2014;25(10):1271-1281.
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8
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Canadian Cancer
Society. Cancerous tumours of the kidney. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/kidney-cancer/cancerous-tumours/?region=on. Accessed
on January 22, 2020.
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9
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Canadian Cancer
Society. Survival statistics for kidney cancer. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/statistics/?region=on.
Accessed on October 8, 2019.
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10
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Canadian Cancer
Society. Kidney cancer statistics. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/statistics/?region=on.
Accessed on October 8, 2019.
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11
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Canadian Cancer
Society. Risk factors for kidney cancer. Available at
http://www.cancer.ca/en/cancer-information/cancer-type/kidney/risks/?region=on. Accessed
on January 22, 2020.
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SOURCE Merck