Approval is based on the Phase 3 KEYNOTE-716
Trial
Melanoma is the most serious of all skin
cancers, with over 5,000 Canadians diagnosed each
year.1,2
KIRKLAND, QC, Sept. 13,
2022 /CNW/ - Merck (NYSE: MRK), known as MSD outside
the United States and Canada, announced that Health Canada has
granted approval for KEYTRUDA® (pembrolizumab), Merck's
anti-PD-1 therapy, for the adjuvant treatment of adult and
pediatric (12 years and older) patients with stage IIB or IIC
melanoma following complete resection.3 This
approval is based on the results from the Phase 3 KEYNOTE-716
trial, which demonstrated a statistically significant improvement
in recurrence-free survival (RFS).3
In 2022, an estimated 9,000 Canadians will be diagnosed with
melanoma,4 a form of cancer that takes place when
melanocytes, the cells responsible for melanin production, start to
grow uncontrollably and develop into a
tumour.5 Although it is the least common of all
skin cancers, melanoma is the most serious type and early diagnosis
and treatment are
critical.1,5
"We welcome the news of a new treatment option for Canadians
living with this disease as the incidence of melanoma continues to
rise across the
country,"6,8 said
Kathy Barnard, Founder/President of
Save Your Skin Foundation. "Having options available right after
surgery can help take action against a disease that moves quickly
if not caught."
"Melanoma can affect anyone, including children, for whom,
although rare, this is the most common amongst pediatric skin
cancer types,"7 said Falyn
Katz, Executive Director, Melanoma Canada. "Having options
available, like this one, can help to make a difference for
Canadians facing this particular type of skin cancer, helping them
navigate the disease."
About KEYNOTE-716 Trial
Health Canada's approval is based on findings from
KEYNOTE-716, a multicenter, randomized, double-blind,
placebo-controlled clinical trial in patients (n=976) with
completely resected stage IIB or IIC
melanoma.3 Only patients that had not been
previously treated for melanoma beyond complete surgical resection
for their melanoma prior to study entry were included in the
trial.3 Patients were randomized to
KEYTRUDA® 200 mg or the pediatric (≥12 years old)
dose of KEYTRUDA® 2 mg/kg intravenously (up to a maximum
of 200 mg) every three weeks (n=487) or placebo (n=489) for up to
one year until disease recurrence or unacceptable
toxicity.3 The primary efficacy outcome was
investigator-assessed recurrence-free survival (RFS). RFS was
defined as the time between the date of randomization and the date
of first recurrence (local, regional, or distant metastasis) or
death, whichever occurs first.3
The results of KEYNOTE-716 demonstrated a statistically
significant improvement in RFS for patients randomized to receive
KEYTRUDA® compared with patients randomized to placebo
at the first pre-specified interim analysis.3 At
the time of median follow-up (14.3 months), 11% (n=54/487) of
patients who received KEYTRUDA® had a recurrence or
died compared to 17% (n=82/489) of patients who received
placebo.
In the study, the safety profile of KEYTRUDA® was
consistent with previously reported studies in patients with solid
tumors. The most common treatment-related adverse events (reported
in at least 15% of patients) were pruritis, fatigue, diarrhea, and
rash. KEYTRUDA® was discontinued for treatment-related
adverse events in 15% of patients in KEYNOTE-716. Refer to the
product monograph for complete information.3
"This approval is important for people living with melanoma and
for all of us at Merck," said Marwan
Akar, President, and Managing Director, Merck Canada. "With
this new indication, KEYTRUDA® is the first checkpoint
inhibitor approved in Canada in
the adjuvant space in Stage IIB or IIC melanoma, meaning it can be
considered for patients earlier in their journey. We are proud to
continue to pursue our passion to save and improve lives as well as
reinforce our commitment to finding innovative and effective
options for more patients with melanoma."
About Melanoma
Melanoma is a form of skin cancer that
starts in the melanocyte cells of the
skin.5 Although less common than other forms of
skin cancer, melanoma is the most serious type.5
Incidences of melanoma are higher in men than in women, and the
risk tends to increase with age.8 Major causes
include chronic exposure to ultraviolet radiation from sunlight or
other artificial sources.1
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.3 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.3
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, esophageal cancer, triple-negative breast
cancer, melanoma, and head and neck squamous cell
carcinoma.3
Our Focus on Cancer
Our goal is to translate
progressive science into innovative oncology medicines to help
people with cancer worldwide. At Merck Canada, helping people fight
cancer is our passion and supporting accessibility to our cancer
medicines is our commitment. Our focus is on pursuing research in
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
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 YouTube and Twitter @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 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 2021
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/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf
References
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|
1 Canadian
Skin Cancer Foundation. Malignant Melanoma. Taken
from:
https://www.canadianskincancerfoundation.com/skin-cancer/malignant-melanoma/.
Accessed on July 7, 2022.
2 Canadian Skin Cancer Foundation. Skin
Cancer. Taken from:
https://www.canadianskincancerfoundation.com/skin-cancer/. Accessed
on July 8, 2022.
3 KEYTRUDA® Product Monograph. Merck
Canada Inc. Updated August 18, 2022. Available at:
https://www.merck.ca/en/wp-content/uploads/sites/20/2021/04/KEYTRUDA-PM_E.pdf
4 Canadian Cancer Society. Melanoma Skin Cancer
Statistics. Taken from:
https://cancer.ca/en/cancer-information/cancer-types/skin-melanoma/statistics.
Accessed on July 7, 2022.
5 Government of Canada. Melanoma Skin
Cancer. Taken from:
https://www.canada.ca/en/public-health/services/chronic-diseases/cancer/melanoma-skin-cancer.html.
Accessed on July 7, 2022.
6 Conte et al. Population-Based Study Detailing
Cutaneous Melanoma Incidence and Mortality Trends in Canada.
Taken from:
https://www.frontiersin.org/articles/10.3389/fmed.2022.830254/full.
Accessed on July 7, 2022.
7 St. Jude Children's Research Hospital.
Melanoma. Taken from:
https://www.stjude.org/disease/melanoma.html. Accessed on July 7,
2022.
8 Canadian Cancer Society. Risk Factors for
Melanoma Skin Cancer. Taken from:
https://cancer.ca/en/cancer-information/cancer-types/skin-melanoma/risks.
Accessed on July 7, 2022.
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®Merck Sharp & Dohme LLC, used under license.
SOURCE Merck Canada