WOODCLIFF LAKE, N.J. and
KENILWORTH, N.J., Aug. 17, 2018 /PRNewswire/ -- Eisai Inc. and
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and
Drug Administration (FDA) approved the kinase inhibitor
LENVIMA® (lenvatinib) for the first-line treatment of
patients with unresectable hepatocellular carcinoma (HCC). This
approval was based on results from REFLECT (Study 304), where
LENVIMA demonstrated a proven treatment effect on overall survival
(OS) by statistical confirmation of non-inferiority, as well as
statistically significant superiority and clinically meaningful
improvements in progression-free survival (PFS) and objective
response rate (ORR) when compared with sorafenib in patients with
previously untreated unresectable HCC.
Experience the interactive Multichannel News Release here:
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"Unresectable hepatocellular carcinoma is an extremely
difficult-to-treat cancer, with no new first-line systemic therapy
options for more than a decade," said Dr. Ghassan Abou-Alfa,
medical oncologist, Memorial Sloan Kettering Cancer Center.
"REFLECT is the first-ever positive Phase 3 trial against an active
comparator in unresectable HCC. The efficacy and safety data from
REFLECT are important findings for oncologists and others in the
multidisciplinary teams who treat liver cancer, as well as for our
patients who are affected by it."
Adverse reactions, some of which can be serious or fatal, may
occur with LENVIMA, including hypertension, cardiac dysfunction,
arterial thromboembolic events, hepatotoxicity, renal failure or
impairment, proteinuria, diarrhea, fistula formation and
gastrointestinal perforation, QT interval prolongation,
hypocalcemia, reversible posterior leukoencephalopathy syndrome,
hemorrhagic events, impairment of thyroid stimulating hormone
suppression/thyroid dysfunction, and wound healing complications.
Based on the severity of the adverse reaction, LENVIMA should be
monitored, withheld or discontinued. Based on its mechanism of
action and data from animal reproduction studies, LENVIMA can cause
fetal harm when administered to a pregnant woman. Females of
reproductive potential should be advised to use effective
contraception. For more information, see "Important Safety
Information" below.
REFLECT showed that LENVIMA achieved the primary endpoint,
demonstrating a treatment effect on OS by statistical confirmation
of non-inferiority to sorafenib. Patients treated with LENVIMA
experienced a median OS of 13.6 months compared to 12.3 months with
sorafenib (HR: 0.92; 95% CI: 0.79–1.06). The OS analysis was
conducted when 351 events had occurred in the LENVIMA arm and 350
events had occurred in the sorafenib arm, as prespecified in the
statistical analysis plan. In addition, LENVIMA showed
statistically significant superiority and clinically meaningful
improvements in the secondary efficacy endpoints of PFS and ORR, as
confirmed by a blinded independent imaging review (IIR):
- Median PFS was doubled with LENVIMA compared to sorafenib: 7.3
months versus 3.6 months (HR: 0.64; 95% CI: 0.55–0.75; p<0.001)
per blinded independent imaging review based on mRECIST criteria,
and 7.3 months with LENVIMA versus 3.6 months with sorafenib (HR:
0.65; 95% CI: 0.56–0.77) per RECIST 1.1.
- LENVIMA showed nearly 3.5 times the ORR of sorafenib: 41% (95%
CI: 36-45%) vs. 12% (95% CI: 10-16%) per blinded independent
imaging review based on mRECIST criteria, respectively
(p<0.001), and 19% (95% CI: 15-22%) with LENVIMA versus 7% (95%
CI: 4-9%) with sorafenib per RECIST 1.1.
-
- Per mRECIST: Treatment with LENVIMA resulted in complete
response (CR) = 2.1% (n=10) vs. 0.8% (n=4) with sorafenib;
treatment with LENVIMA resulted in partial response (PR) = 38.5%
(n=184) vs. 11.6% (n=55) with sorafenib
- Per RECIST 1.1: Treatment with LENVIMA resulted in CR = 0.4%
(n=2) vs. 0.2% (n=1) with sorafenib; treatment with LENVIMA
resulted in PR = 18.4% (n=88) vs. 6.3% (n=30) with sorafenib
In addition, median time to progression (TTP) was doubled with
LENVIMA compared to sorafenib: 7.4 months versus 3.7 months (HR:
0.60; 95% CI: 0.51–0.71; p<0.0001) per blinded independent
imaging review based on mRECIST criteria, and 7.4 months with
LENVIMA versus 3.7 months with sorafenib (HR: 0.61; 95% CI:
0.51–0.72; p<0.0001) per RECIST 1.1. Time to progression is
defined as time from randomization to radiological progression.
Deaths during follow-up without evidence of radiological
progression are censored. This differs from PFS and is less
correlative to overall survival.
In REFLECT, the most common adverse reactions (≥20%) observed in
patients treated with LENVIMA were hypertension, fatigue, diarrhea,
decreased appetite, arthralgia/myalgia, decreased weight, abdominal
pain, palmar-plantar erythrodysesthesia syndrome, proteinuria,
dysphonia, hemorrhagic events, hypothyroidism and nausea. The most
common serious adverse reactions (≥2%) reported in patients treated
with LENVIMA were hepatic encephalopathy (5%), hepatic failure
(3%), ascites (3%) and decreased appetite (2%).
The most common adverse reactions (≥20%) observed in patients
who received sorafenib were palmar-plantar erythrodysesthesia
syndrome, diarrhea, fatigue, hypertension, abdominal pain,
decreased appetite, rash, decreased weight and arthralgia/myalgia.
The most common serious adverse reactions (≥2%) reported in
patients who received sorafenib were ascites (2%) and abdominal
pain (2%).
It is also important to note that the dose for LENVIMA for
patients with unresectable HCC is based on the patient's weight (12
mg for patients weighing 60 kilograms or more, 8 mg for patients
weighing less than 60 kilograms); the recommended dosage and dose
adjustments are described in the full prescribing information.
"Eisai strives to be a leading global R&D-based
pharmaceutical company, driven by our human health care
(hhc) mission to improve the lives of patients and their
loved ones," said Shaji Procida,
President and Chief Operating Officer, Eisai Inc., and Commercial
Head of the Oncology Business Group, Americas at Eisai. "That
purpose is what has propelled us toward this win for patients with
unresectable hepatocellular carcinoma. Our goal is to bring
monumental solutions to patients and health care providers,
changing expectations for the oncology landscape, and we look
forward to continuing this work in our ongoing collaboration with
Merck."
"We are pleased by the FDA approval of LENVIMA as it marks an
important advancement in the treatment of unresectable
hepatocellular carcinoma," said Dr. Roy
Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck Research Laboratories.
"With our shared mission to find solutions for difficult-to-treat
cancers, we look forward to working with Eisai to help bring this
needed option to patients and physicians."
LENVIMA, a kinase inhibitor, was first approved in the U.S. in
February 2015 for patients with locally recurrent or metastatic,
progressive, radioactive iodine-refractory differentiated thyroid
cancer (DTC). In May 2016, LENVIMA was approved in the U.S. in
combination with everolimus, for patients with advanced renal cell
carcinoma (RCC) following one prior anti-angiogenic therapy. Under
the collaboration, Eisai and Merck initiated co-commercialization
activities for LENVIMA in the U.S. in June 2018. Since the initial
launch, more than 10,000 patients were treated with LENVIMA, which
is approved in more than 50 countries worldwide.
About the REFLECT Trial (Study 304)
REFLECT was a large (N=954) phase 3, randomized, multicenter,
open-label trial conducted by Eisai to compare the efficacy and
safety of lenvatinib versus sorafenib as a first-line systemic
treatment in patients with unresectable hepatocellular carcinoma
(HCC). Patients at 154 trial sites in 20 countries were randomized
to receive lenvatinib 12 mg or 8 mg once a day depending on body
weight (≥60 kg or <60 kg, respectively) (n=478) or sorafenib 400
mg twice a day (n=476). Treatment was continued until disease
progression or unacceptable toxicity. The primary endpoint of this
study was overall survival, tested first for non-inferiority to
sorafenib, then for superiority. Patients randomized to the LENVIMA
arm did not have a statistically significant improvement in OS
compared to those in the sorafenib arm. The key secondary efficacy
endpoints of this study included progression-free survival, time to
progression and objective response rate, tested for superiority to
sorafenib. The results of the REFLECT trial were published online
in The Lancet (Vol 391(10126):1163-1173) on February 9,
2018.
About Unresectable Hepatocellular Carcinoma (HCC)
The
prevalence and mortality rate of hepatocellular carcinoma have been
rising steadily over the past decade. Hepatocellular carcinoma is
the most common type of liver cancer, accounting for about 90% of
cases of primary liver cancer. The stage of disease at diagnosis
largely determines treatment approach, with potentially curative
options, like resection or transplantation, only available for
early stage HCC. Unresectable HCC, a type of liver cancer that
cannot be removed by surgery, has a worse prognosis, with a median
survival of less than one year. Unfortunately, approximately 70% of
patients are diagnosed too late to be eligible for resection or
transplantation, and there have been limited treatment options
available for patients with unresectable disease.
About LENVIMA® (lenvatinib) capsules 10 mg and 4
mg
LENVIMA® (lenvatinib) is a kinase inhibitor
that is indicated for the treatment of:
- Patients with locally recurrent or metastatic, progressive
radioactive iodine-refractory differentiated thyroid cancer
(DTC)
- In combination with everolimus, for the treatment of patients
with advanced renal cell carcinoma (RCC) following one prior
anti-angiogenic therapy
- For the first-line treatment of patients with unresectable
hepatocellular carcinoma (HCC)
LENVIMA, discovered and developed by Eisai, is a kinase
inhibitor that 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. Lenvatinib also exhibited antiproliferative activity in
hepatocellular carcinoma cell lines dependent on activated FGFR
signaling with a concurrent inhibition of FGF-receptor substrate 2α
(FRS2α) phosphorylation.
Important Safety Information
Warnings and Precautions
Hypertension. In DTC, hypertension occurred in 73%
of patients on LENVIMA (44% grade 3-4). In RCC, hypertension
occurred in 42% of patients on LENVIMA + everolimus (13% grade 3).
Systolic blood pressure ≥160 mmHg occurred in 29% of patients, and
21% had diastolic blood pressure ≥100 mmHg. In HCC, hypertension
occurred in 45% of LENVIMA-treated patients (24% grade 3). Grade 4
hypertension was not reported in HCC.
Serious complications of poorly controlled hypertension have
been reported. Control blood pressure prior to initiation. Monitor
blood pressure after 1 week, then every 2 weeks for the first 2
months, and then at least monthly thereafter during treatment.
Withhold and resume at reduced dose when hypertension is controlled
or permanently discontinue based on severity.
Cardiac Dysfunction. Serious and fatal cardiac
dysfunction can occur with LENVIMA. Across clinical trials in 799
patients with DTC, RCC, and HCC, grade 3 or higher cardiac
dysfunction occurred in 3% of LENVIMA-treated patients. Monitor for
clinical symptoms or signs of cardiac dysfunction. Withhold and
resume at reduced dose upon recovery or permanently discontinue
based on severity.
Arterial Thromboembolic Events. Among patients
receiving LENVIMA or LENVIMA + everolimus, arterial thromboembolic
events of any severity occurred in 2% of patients in RCC and HCC
and 5% in DTC. Grade 3-5 arterial thromboembolic events ranged from
2% to 3% across all clinical trials.
Permanently discontinue following an arterial thrombotic event.
The safety of resuming after an arterial thromboembolic event has
not been established and LENVIMA has not been studied in patients
who have had an arterial thromboembolic event within the previous 6
months.
Hepatotoxicity. Across clinical studies enrolling
1,327 LENVIMA-treated patients with malignancies other than HCC,
serious hepatic adverse reactions occurred in 1.4% of patients.
Fatal events, including hepatic failure, acute hepatitis and
hepatorenal syndrome, occurred in 0.5% of patients. In HCC, hepatic
encephalopathy occurred in 8% of LENVIMA-treated patients (5% grade
3-5). Grade 3-5 hepatic failure occurred in 3% of LENVIMA-treated
patients. 2% of patients discontinued LENVIMA due to hepatic
encephalopathy and 1% discontinued due to hepatic failure.
Monitor liver function prior to initiation, then every 2 weeks
for the first 2 months, and at least monthly thereafter during
treatment. Monitor patients with HCC closely for signs of hepatic
failure, including hepatic encephalopathy. Withhold and resume at
reduced dose upon recovery or permanently discontinue based on
severity.
Renal Failure or Impairment. Serious including
fatal renal failure or impairment can occur with LENVIMA. Renal
impairment was reported in 14% and 7% of LENVIMA-treated patients
in DTC and HCC, respectively. Grade 3-5 renal failure or impairment
occurred in 3% of patients with DTC and 2% of patients with HCC,
including 1 fatal event in each study. In RCC, renal impairment or
renal failure was reported in 18% of LENVIMA + everolimus–treated
patients (10% grade 3).
Initiate prompt management of diarrhea or
dehydration/hypovolemia. Withhold and resume at reduced dose upon
recovery or permanently discontinue for renal failure or impairment
based on severity.
Proteinuria. In DTC and HCC, proteinuria was
reported in 34% and 26% of LENVIMA-treated patients, respectively.
Grade 3 proteinuria occurred in 11% and 6% in DTC and HCC,
respectively. In RCC, proteinuria occurred in 31% of patients
receiving LENVIMA + everolimus (8% grade 3).
Monitor for proteinuria prior to initiation and periodically
during treatment. If urine dipstick proteinuria ≥2+ is detected,
obtain a 24-hour urine protein. Withhold and resume at reduced dose
upon recovery or permanently discontinue based on severity.
Diarrhea. Of the 737 LENVIMA-treated patients in
DTC and HCC, diarrhea occurred in 49% (6% grade 3). In RCC,
diarrhea occurred in 81% of LENVIMA + everolimus–treated patients
(19% grade 3). Diarrhea was the most frequent cause of dose
interruption/reduction, and diarrhea recurred despite dose
reduction.
Promptly initiate management of diarrhea. Withhold and resume at
reduced dose upon recovery or permanently discontinue based on
severity.
Fistula Formation and Gastrointestinal Perforation.
Of the 799 patients treated with LENVIMA or LENVIMA + everolimus in
DTC, RCC, and HCC, fistula or gastrointestinal perforation occurred
in 2%. Fistulas and gastrointestinal perforations have also been
reported in other lenvatinib clinical trials and in post-marketing
experience. Pneumothorax has been reported with and without clear
evidence of a bronchopleural fistula. Some reports of
gastrointestinal perforation, fistula, and pneumothorax occurred in
association with tumor regression or necrosis. In most cases of
fistula formation or gastrointestinal perforation, risk factors
such as prior surgery or radiotherapy were present.
Permanently discontinue in patients who develop gastrointestinal
perforation of any severity or grade 3-4 fistula.
QT Interval Prolongation. In DTC, QT/QTc interval
prolongation occurred in 9% of LENVIMA-treated patients and QT
interval prolongation of >500 ms occurred in 2%. In RCC, QTc
interval increases of >60 ms occurred in 11% of patients
receiving LENVIMA + everolimus and QTc interval >500 ms occurred
in 6%. In HCC, QTc interval increases of >60 ms occurred in 8%
of LENVIMA-treated patients and QTc interval >500 ms occurred in
2%.
Monitor and correct electrolyte abnormalities at baseline and
periodically during treatment. Monitor electrocardiograms in
patients with congenital long QT syndrome, congestive heart
failure, bradyarrhythmias, or those who are taking drugs known to
prolong the QT interval, including Class Ia and III
antiarrhythmics. Withhold and resume at reduced dose upon recovery
based on severity.
Hypocalcemia. In DTC, grade 3-4 hypocalcemia
occurred in 9% of LENVIMA-treated patients. In 65% of cases,
hypocalcemia improved or resolved following calcium supplementation
with or without dose interruption or dose reduction. In RCC, grade
3-4 hypocalcemia occurred in 6% of LENVIMA + everolimus–treated
patients. In HCC, grade 3 hypocalcemia occurred in 0.8% of
LENVIMA-treated patients.
Monitor blood calcium levels at least monthly and replace
calcium as necessary during treatment. Withhold and resume at
reduced dose upon recovery or permanently discontinue depending on
severity.
Reversible Posterior Leukoencephalopathy Syndrome.
Across clinical studies of 1,823 patients who received LENVIMA as a
single agent, RPLS occurred in 0.3%. Confirm diagnosis of RPLS with
MRI. Withhold and resume at reduced dose upon recovery or
permanently discontinue depending on severity and persistence of
neurologic symptoms.
Hemorrhagic Events. Serious including fatal
hemorrhagic events can occur with LENVIMA. In DTC, RCC, and HCC
clinical trials, hemorrhagic events, of any grade, occurred in 29%
of the 799 patients treated with LENVIMA as a single agent or in
combination with everolimus. The most frequently reported
hemorrhagic events (all grades and occurring in at least 5% of
patients) were epistaxis and hematuria. In DTC, grade 3-5
hemorrhage occurred in 2% of LENVIMA-treated patients, including 1
fatal intracranial hemorrhage among 16 patients who received
LENVIMA and had CNS metastases at baseline. In RCC, grade 3-5
hemorrhage occurred in 8% of LENVIMA + everolimus–treated patients,
including 1 fatal cerebral hemorrhage. In HCC, grade 3-5 hemorrhage
occurred in 5% of LENVIMA-treated patients, including 7 fatal
hemorrhagic events.
Serious tumor-related bleeds, including fatal hemorrhagic
events, occurred in LENVIMA-treated patients in clinical trials and
in the postmarketing setting. In postmarketing surveillance,
serious and fatal carotid artery hemorrhages were seen more
frequently in patients with anaplastic thyroid carcinoma (ATC) than
other tumors. Safety and effectiveness of LENVIMA in patients with
ATC have not been demonstrated in clinical trials.
Consider the risk of severe or fatal hemorrhage associated with
tumor invasion or infiltration of major blood vessels (eg, carotid
artery). Withhold and resume at reduced dose upon recovery or
permanently discontinue based on severity.
Impairment of Thyroid Stimulating Hormone Suppression/Thyroid
Dysfunction. LENVIMA impairs exogenous thyroid
suppression. In DTC, 88% of patients had baseline thyroid
stimulating hormone (TSH) level ≤0.5 mU/L. In patients with normal
TSH at baseline, elevation of TSH level >0.5 mU/L was observed
post baseline in 57% of LENVIMA-treated patients. In RCC and HCC,
grade 1 or 2 hypothyroidism occurred in 24% of LENVIMA +
everolimus–treated patients and 21% of LENVIMA-treated patients,
respectively. In patients with normal or low TSH at baseline,
elevation of TSH was observed post baseline in 70% of
LENVIMA-treated patients in HCC and 60% of LENVIMA +
everolimus–treated patients in RCC.
Monitor thyroid function prior to initiation and at least
monthly during treatment. Treat hypothyroidism according to
standard medical practice.
Wound Healing Complications. Wound healing
complications, including fistula formation and wound dehiscence,
can occur with LENVIMA. Withhold for at least 6 days prior to
scheduled surgery. Resume after surgery based on clinical judgment
of adequate wound healing. Permanently discontinue in patients with
wound healing complications.
Embryo-fetal Toxicity. Based on its mechanism of
action and data from animal reproduction studies, LENVIMA can cause
fetal harm when administered to pregnant women. In animal
reproduction studies, oral administration of lenvatinib during
organogenesis at doses below the recommended clinical doses
resulted in embryotoxicity, fetotoxicity, and teratogenicity in
rats and rabbits. Advise pregnant women of the potential risk to a
fetus; and advise females of reproductive potential to use
effective contraception during treatment with LENVIMA and for at
least 30 days after the last dose.
Adverse Reactions
In DTC, the most common adverse
reactions (≥30%) observed in LENVIMA-treated patients were
hypertension (73%), fatigue (67%), diarrhea (67%),
arthralgia/myalgia (62%), decreased appetite (54%), decreased
weight (51%), nausea (47%), stomatitis (41%), headache (38%),
vomiting (36%), proteinuria (34%), palmar-plantar
erythrodysesthesia syndrome (32%), abdominal pain (31%), and
dysphonia (31%). The most common serious adverse reactions (≥2%)
were pneumonia (4%), hypertension (3%), and dehydration (3%).
Adverse reactions led to dose reductions in 68% of LENVIMA-treated
patients; 18% discontinued LENVIMA. The most common adverse
reactions (≥10%) resulting in dose reductions were hypertension
(13%), proteinuria (11%), decreased appetite (10%), and diarrhea
(10%); the most common adverse reactions (≥1%) resulting in
discontinuation of LENVIMA were hypertension (1%) and asthenia
(1%).
In RCC, the most common adverse reactions (≥30%) observed in
LENVIMA + everolimus–treated patients were diarrhea (81%), fatigue
(73%), arthralgia/myalgia (55%), decreased appetite (53%), vomiting
(48%), nausea (45%), stomatitis (44%), hypertension (42%),
peripheral edema (42%), cough (37%), abdominal pain (37%), dyspnea
(35%), rash (35%), decreased weight (34%), hemorrhagic events
(32%), and proteinuria (31%). The most common serious adverse
reactions (≥5%) were renal failure (11%), dehydration (10%), anemia
(6%), thrombocytopenia (5%), diarrhea (5%), vomiting (5%), and
dyspnea (5%). Adverse reactions led to dose reductions or
interruption in 89% of patients. The most common adverse reactions
(≥5%) resulting in dose reductions were diarrhea (21%), fatigue
(8%), thrombocytopenia (6%), vomiting (6%), nausea (5%), and
proteinuria (5%). Treatment discontinuation due to an adverse
reaction occurred in 29% of patients.
In HCC, the most common adverse reactions (≥20%) observed in
LENVIMA-treated patients were hypertension (45%), fatigue (44%),
diarrhea (39%), decreased appetite (34%), arthralgia/myalgia (31%),
decreased weight (31%), abdominal pain (30%), palmar-plantar
erythrodysesthesia syndrome (27%), proteinuria (26%), dysphonia
(24%), hemorrhagic events (23%), hypothyroidism (21%), and nausea
(20%). The most common serious adverse reactions (≥2%) were hepatic
encephalopathy (5%), hepatic failure (3%), ascites (3%), and
decreased appetite (2%). Adverse reactions led to dose reductions
or interruption in 62% of patients. The most common adverse
reactions (≥5%) resulting in dose reductions were fatigue (9%),
decreased appetite (8%), diarrhea (8%), proteinuria (7%),
hypertension (6%), and palmar-plantar erythrodysesthesia syndrome
(5%). Treatment discontinuation due to an adverse reaction occurred
in 20% of patients. The most common adverse reactions (≥1%)
resulting in discontinuation of LENVIMA were fatigue (1%), hepatic
encephalopathy (2%), hyperbilirubinemia (1%), and hepatic failure
(1%).
Use in Specific Populations
Because of the potential
for serious adverse reactions in breastfed infants, advise women to
discontinue breastfeeding during treatment and for at least 1 week
after last dose. LENVIMA may impair fertility in males and females
of reproductive potential.
No dose adjustment is recommended for patients with mild (CLcr
60-89 mL/min) or moderate (CLcr 30-59 mL/min) renal impairment.
LENVIMA concentrations may increase in patients with DTC or RCC and
severe (CLcr 15-29 mL/min) renal impairment. Reduce the dose for
patients with RCC or DTC and severe renal impairment. There is no
recommended dose for patients with HCC and severe renal impairment.
LENVIMA has not been studied in patients with end stage renal
disease.
No dose adjustment is recommended for patients with HCC and mild
hepatic impairment (Child-Pugh A). There is no recommended dose for
patients with HCC with moderate (Child-Pugh B) or severe
(Child-Pugh C) hepatic impairment.
No dose adjustment is recommended for patients with DTC or RCC
and mild or moderate hepatic impairment. LENVIMA concentrations may
increase in patients with DTC or RCC and severe hepatic impairment.
Reduce the dose for patients with DTC or RCC and severe hepatic
impairment.
For more information about LENVIMA please see available full
Prescribing Information.
About the Eisai and Merck Strategic Collaboration
In
March 2018, Eisai and Merck, through
an affiliate, entered into a strategic collaboration for the
worldwide co-development and co-commercialization of
LENVIMA® (lenvatinib). Under the agreement, the
companies will jointly develop and commercialize LENVIMA, both as
monotherapy and in combination with Merck's anti-PD-1 therapy
KEYTRUDA® (pembrolizumab). In addition to ongoing
clinical studies of the combination, the companies will jointly
initiate new clinical studies evaluating the LENVIMA/KEYTRUDA
combination to support 11 potential indications in six types of
cancer, as well as a basket trial targeting six additional cancer
types. The LENVIMA/KEYTRUDA combination is not approved in any
cancer types today.
About Eisai Inc.
At Eisai Inc., human health
care (hhc) is our goal. We give our first thoughts to
patients and their families, and helping to increase the benefits
health care provides. As the U.S. pharmaceutical subsidiary of
Tokyo-based Eisai Co., Ltd., we
have a passionate commitment to patient care that is the driving
force behind our efforts to discover and develop innovative
therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that
operates in two global business groups: oncology and neurology
(dementia-related diseases and neurodegenerative diseases). Each
group functions as an end-to-end global business with discovery,
development, manufacturing and marketing capabilities. Our U.S.
headquarters, commercial and clinical development organizations are
located in New Jersey; our
discovery labs are in Massachusetts and Pennsylvania; and our global demand chain
organization resides in Maryland
and North Carolina. To learn more
about Eisai Inc., please visit us at eisai.com/us and follow us on
Twitter and LinkedIn.
Merck's Focus on Cancer
Our goal is to translate
breakthrough science into innovative oncology medicines to help
people with cancer worldwide. At Merck, the potential to bring new
hope to people with cancer drives our purpose and supporting
accessibility to our cancer medicines is our commitment.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the largest
development programs in the industry across more than 30 tumor
types. We also continue to strengthen our portfolio through
strategic acquisitions and are prioritizing the development of
several promising oncology candidates with the potential to improve
the treatment of advanced cancers.
For more information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
For more than 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,
visit www.merck.com and connect with us on Twitter,
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Kenilworth, N.J., USA
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the necessary regulatory approvals or that they will prove to be
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SOURCE Eisai Inc.