KIRKLAND, QC, and MISSISSAUGA, ON, Dec. 21,
2023 /CNW/ - Merck (NYSE: MRK), known as MSD outside
the United States and Canada, and Eisai announce that
KEYTRUDA®, Merck's anti-PD-1 therapy, plus
LENVIMA®, an orally available multiple receptor tyrosine
kinase inhibitor discovered by Eisai, is now reimbursed with
clinical criteria and conditions under the British Columbia, Alberta, Saskatchewan, Ontario, Quebec, Nova
Scotia, New Brunswick, and
Newfoundland drug plans, for adult
patients with advanced endometrial carcinoma (EC) that is not
microsatellite instability high (MSI-H) or mismatch repair
deficient (dMMR), who have disease progression following prior
platinum-based systemic therapy, and are not candidates for
curative surgery or radiation.
This announcement follows the notice of compliance issuance from
Health Canada in July 2023 based on
the results from the Phase 3 Study 309/KEYNOTE-775 trial, which
evaluated KEYTRUDA® plus LENVIMA® versus
chemotherapy (treatment of physician's choice of doxorubicin or
paclitaxel) in patients with advanced endometrial carcinoma who had
been previously treated with at least one prior platinum-based
chemotherapy regimen in any setting. KEYTRUDA® plus
LENVIMA® demonstrated statistically significant
improvements in the dual primary endpoints of overall survival (OS)
and progression-free-survival (PFS) compared to chemotherapy.
"Each patient's journey is unique, and this particular
indication addresses an important care gap as it targets
individuals that are diagnosed in a late stage setting with limited
treatment options," says Dr. Amit
Oza, Head of the Division of Medical Oncology &
Hematology, Professor of Medicine, University
of Toronto, and Medical Director of the Cancer Clinical
Research Unit at Princess Margaret Cancer Centre. "By having an
additional therapeutic option in our toolbox, we are better able to
tailor treatment plans according to individual needs, which can
help improve health outcomes."
These most recent developments are a result of the strategic
collaboration between Merck and Eisai, whose collective mission is
to help bring greater access to innovative medicines for patients
in need.
"Endometrial cancer is a serious and potentially
life-threatening condition affecting many Canadians," says
Patrick Forsythe, Country Manager,
Eisai Canada. "We commend Health Canada and the health technology
assessment organizations for supporting the approval and
availability of KEYTRUDA® plus LENVIMA® to
provide an additional treatment option in an area of oncology where
cases are rising in this country."
"This achievement is a result of the relentless work of our
researchers and physicians, as well as the commitment of the
patients who enroll in these clinical trials," says André
Galarneau, Executive Director & Vice President, Oncology
Business Unit at Merck Canada. "It is thanks to them that we can
provide more treatment options to Canadians impacted by this
disease."
About STUDY 309/KEYNOTE-775
Study 309/KEYNOTE-775 is a Phase 3 multicenter, open-label,
randomized, active-controlled trial that enrolled 827 patients with
advanced EC previously treated with at least one prior
platinum-based chemotherapy regimen in any setting, including in
the neoadjuvant and adjuvant settings. The study excluded certain
patients such as those with endometrial sarcoma, including
carcinosarcoma, or patients who had active autoimmune disease or a
medical condition that required immunosuppression. The primary
efficacy outcome measures were OS and PFS as assessed by blinded
independent central review (BICR) according to Response Evaluation
Criteria in Solid Tumors Version (RECIST) v1.1. Secondary efficacy
outcome measures included ORR as assessed by BICR.
There were 697 patients with advanced EC that was not MSI-H or
dMMR that were randomized 1:1 to receive pembrolizumab (200 mg
intravenously every three weeks) plus lenvatinib (20 mg orally
once daily or n=346 ) or investigator's choice, consisting of
either doxorubicin (60 mg/m2 every three weeks;
n=254) or paclitaxel (80 mg/m2 given weekly, three
weeks on/one week off; n=97). Treatment with pembrolizumab plus
lenvatinib continued until RECIST v1.1-defined progression of
disease as verified by BICR, unacceptable toxicity, or for
pembrolizumab, a maximum of 24 months or up to 35 administrations -
whichever was longer. Administration of pembrolizumab plus
lenvatinib was permitted beyond RECIST-defined disease
progression if the treating investigator considered the patient to
be deriving clinical benefit and the treatment was.
The most common adverse events (reported in at least 30% of
patients) among these patients receiving pembrolizumab and
lenvatinib were hypothyroidism, hypertension, fatigue, diarrhea,
musculoskeletal disorders, nausea, decreased appetite, vomiting,
stomatitis, abdominal pain, weight loss, and urinary tract
infection.
About Endometrial Carcinoma
Endometrial carcinoma (endometrial cancer) begins in the inner
lining of the uterus, and makes up more than 95% of all uterine
cancer cases. In 2023, an estimated 8,500 Canadian women will be
diagnosed with uterine cancer, with a greater tendency to develop
in women over the age of 50. Symptoms of endometrial cancer can
include abnormal vaginal bleeding, pain during intercourse,
difficult or painful urination and pain in the pelvic area.
About KEYTRUDA®
(pembrolizumab)
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, esophageal cancer, triple-negative breast
cancer, melanoma, and head and neck squamous cell carcinoma.
About LENVIMA®
(lenvatinib)
LENVIMA®, discovered and developed
by Eisai, is an orally available multiple receptor tyrosine kinase
inhibitor that selectively inhibits the kinase activities of
vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1),
VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA® inhibits other
kinases that have been implicated in pathogenic angiogenesis, tumor
growth, and cancer progression in addition to their normal cellular
functions, including fibroblast growth factor (FGF) receptors
FGFR1-4, the platelet derived growth factor receptor alpha
(PDGFRα), KIT, and RET. In syngeneic mouse tumor models,
LENVIMA® decreased tumor-associated macrophages,
increased activated cytotoxic T cells, and demonstrated greater
antitumor activity in combination with an anti-PD-1 monoclonal
antibody compared to either treatment alone.
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.
About Eisai
Eisai's Corporate Concept is "to give
first thought to patients and the people in the daily living
domain, and to increase the benefits that healthcare provides."
Under this Concept [also known as our human health
care (hhc) Concept], we aim to effectively achieve
social good in the form of relieving anxiety over health and
reducing health disparities. With a global network of R&D
facilities, manufacturing sites and marketing subsidiaries, we
strive to create and deliver innovative products to target diseases
with high unmet medical needs, with a particular focus in our
strategic areas of Neurology and Oncology.
In addition, our continued commitment to the elimination of
neglected tropical diseases (NTDs), which is a target (3.3) of
the United Nations Sustainable Development Goals (SDGs), is
demonstrated by our work on various activities together with global
partners.
For more information about Eisai, please
visit www.eisai.com (for global headquarters: Eisai Co.,
Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.)
or www.eisai.eu (for Europe, Middle
East, Africa, Russia, Australia, and New
Zealand headquarters: Eisai Europe Ltd.), and connect with
us on X, formerly known as Twitter (for U.S. and global),
and LinkedIn (for U.S. and EMEA).
Forward-Looking Statement of Merck & Co., Inc.,
Rahway, N.J., 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
candidates that the candidates 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 Annual
Report on Form 10-K for the year ended December 31, 2022 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
Please see the product monograph for
LENVIMA® (lenvatinib)
at:
https://ca.eisai.com/-/media/Files/CanadaEisai/LENVIMA-Product-Monograph-EN.pdf?hash=f43eb602-ffb4-469b-910b-6253e91084bc
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KEYTRUDA® is a
registered trademark of Merck Sharp & Dohme LLC. Used under
license.
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LENVIMA® is part of a
global strategic oncology collaboration between Eisai and
Merck.
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LENVIMA® is a
registered trademark of Eisai R&D Management Co., Ltd.
© 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates.
All rights reserved.
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Media Inquiries: Merck: Mediacanada@merck.com / Eisai:
Michele Randazzo, (551) 427-6722,
Michele_Randazzo@eisai.com
Investor Contacts: Merck: Peter Dannenbaum, (732) 594-1579;
Damini Chokshi, (732) 594-1577 /
Eisai Co., Ltd., Investor Relations: +81-(0) 3-3817-5122
SOURCE Merck Canada Inc.