WOODCLIFF LAKE, N.J.,
May 30, 2015 /PRNewswire/
-- Eisai Inc. announced today the results of its Phase 3 trial
(Study 309), which showed that eribulin met the study's primary
endpoint evaluating overall survival in patients who had advanced
leiomyosarcoma (LMS) or adipocytic sarcoma (ADI), two types of
advanced soft tissue sarcoma. These data will be presented at the
51st Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Chicago as part
of the ASCO press conference on Saturday,
May 30, and also in an oral session on Monday, June 1 at 3:48
p.m. CT (Abstract No. LBA10502).
"For patients with advanced soft tissue sarcoma, outcomes are
often poor and there are limited treatment options," said Patrick
Schöffski, MD, MPH, Department of General Medical Oncology,
University Hospitals Leuven, Belgium. "These results are important in a
disease where so few treatment options exist."
Data from Study 309 demonstrated patients treated with eribulin
(n=228) experienced a median overall survival of 13.5 months
compared to 11.5 months for those treated with dacarbazine (n=224)
(HR 0.768; 95% CI 0.618-0.954; p=0.017). The secondary
endpoints of the Phase 3 trial (Study 309) included
progression-free rate (PFR) at week 12 and progression-free
survival (PFS). While there was a numerical difference in PFR
at week 12 between the eribulin and dacarbazine arms (33% vs 29%),
this was not statistically significant. Median PFS was 2.6 months
in both arms.
Safety was an additional secondary endpoint of Study 309. Data
demonstrated eribulin had a toxicity profile consistent with prior
experience, with no unexpected or new safety findings. In this
study, the most frequent treatment-emergent adverse events in the
eribulin arm were neutropenia, fatigue, nausea, alopecia and
constipation.
Study 309 was a randomized, open-label, multicenter trial of
eribulin mesylate 1.4mg/m2 administered intravenously
(IV) on days one and eight of a 21-day cycle versus dacarbazine IV
on day one, every 21 days (dose range of 850 mg/m2 to
1,200 mg/m2) to patients (n=452) with locally advanced
or recurrent and/or metastatic LMS or ADI who had disease
progression following two standard therapies, one of which must
have been an anthracycline (unless contraindicated).
"Study 309 represents the first investigational Phase 3 trial in
patients with soft tissue sarcoma to demonstrate an overall
survival benefit compared with an active agent," said Kenichi Nomoto, Ph.D., President, Oncology
Product Creation Unit at Eisai Inc. "We are proud of our ongoing
research efforts that may expand the value of existing therapies to
address the unmet medical needs of patients, especially those with
rare and orphan cancers, across the oncology spectrum."
The information discussed in this release presents an
investigational use for an FDA-approved product. It is not intended
to convey conclusions about efficacy and safety. There is no
guarantee that the investigational use of this FDA-approved product
will successfully complete clinical development or gain FDA
approval.
About Soft Tissue Sarcoma
Soft tissue sarcomas are
cancers that develop from cells in the soft, supporting tissues of
the body such as fat, muscle, nerves, fibrous tissues and blood
vessels. The annual incidence of soft tissue sarcoma is
approximately 30 cases per million of the population – equivalent
to less than 1% of all malignant tumors. Soft tissue
sarcomas are mostly diagnosed in early-stage or localized disease,
and many patients are amenable to complete surgical removal, yet
relapse rates can be as high as 50% and outcomes for patients with
advanced disease are poor, with median survival around 1 year or
less.
About Eribulin Mesylate Injection (Available as
Halaven®)
Eribulin is not indicated for
patients with advanced soft tissue sarcoma.
Eribulin mesylate injection is indicated for patients with
metastatic breast cancer who have received at least two
chemotherapeutic regimens for the treatment of metastatic breast
cancer. Prior therapy should have included an anthracycline and a
taxane in either the adjuvant or metastatic setting. Eribulin is a
synthetic analog of halichondrin B, a natural product that was
isolated from the marine sponge Halichondria okadai. First
in the halichondrin class, eribulin is a microtubule dynamics
inhibitor with a distinct binding profile. Based on in vitro
studies, eribulin exerts its effect via a tubulin-based antimitotic
mechanism ultimately leading to apoptotic cell death after
prolonged and irreversible mitotic blockage.
Important Safety Information
Neutropenia
- Monitor complete blood counts prior to each dose, and increase
the frequency of monitoring in patients who develop Grade 3 or 4
cytopenias. Delay administration and reduce subsequent doses in
patients who experience febrile neutropenia or Grade 4 neutropenia
lasting longer than 7 days
- Severe neutropenia (ANC <500/mm3) lasting more
than 1 week occurred in 12% (62/503) of patients. Patients with
elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN
experienced a higher incidence of Grade 4 neutropenia and febrile
neutropenia than patients with normal levels
- Grade 3 and Grade 4 neutropenia occurred in 28% and 29%,
respectively, of patients who received eribulin. Febrile
neutropenia occurred in 5% of patients and two patients (0.4%) died
from complications
Peripheral Neuropathy
- Patients should be monitored closely for signs of peripheral
motor and sensory neuropathy
- Grade 3 peripheral neuropathy occurred in 8% of patients, and
Grade 4 in 0.4% of patients who received eribulin. Delay
administration of eribulin until resolution to Grade 2 or less
- Neuropathy lasting more than 1 year occurred in 5% of patients.
Twenty-two percent of patients developed a new or worsening
neuropathy that had not recovered within a median follow-up
duration of 269 days (range 25-662 days)
- Peripheral neuropathy (5%) was the most common adverse reaction
resulting in discontinuation
Pregnancy Category D
- Eribulin is expected to cause fetal harm when administered to a
pregnant woman and patients should be advised of these risks
QT Prolongation
- In an uncontrolled ECG study in 26 patients, QT prolongation
was observed on Day 8, independent of eribulin concentration, with
no prolongation on Day 1. ECG monitoring is recommended for
patients with congestive heart failure; bradyarrhythmias;
concomitant use of drugs that prolong QT interval, including Class
Ia and III antiarrhythmics; and electrolyte abnormalities
- Correct hypokalemia or hypomagnesemia prior to initiating
eribulin and monitor electrolytes periodically during therapy.
Avoid in patients with congenital long QT syndrome
Hepatic and Renal Impairment
- For patients with mild (Child-Pugh A) or moderate (Child-Pugh
B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal
impairment, a reduction in starting dose is recommended
Most Common Adverse Reactions
- Most common adverse reactions (≥25%) reported in patients
receiving eribulin were neutropenia (82%), anemia (58%),
asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy
(35%), nausea (35%), and constipation (25%)
- The most common serious adverse reactions reported in patients
receiving eribulin were febrile neutropenia (4%) and neutropenia
(2%)
For more information about eribulin, click here for the full
Prescribing Information.
About Eisai Inc.
At Eisai Inc., human health
care 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 help address unmet medical needs. We are a
fully integrated pharmaceutical business with discovery, clinical,
manufacturing and marketing capabilities. Our key areas of
commercial focus include oncology and specialty care (Alzheimer's
disease, epilepsy and metabolic disorders). To learn more about
Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product
creation organization that includes R&D facilities in
Massachusetts, New Jersey, North
Carolina and Pennsylvania,
as well as a global demand chain organization that includes
manufacturing facilities in Maryland and North
Carolina. Eisai's global areas of R&D focus include
neuroscience; oncology; metabolic disorders; vascular, inflammatory
and immunological reaction; and antibody-based programs.
Media
Inquiries
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Landau
Eisai Inc.
(201)
746-2510
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Inquiries
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Eisai Inc.
(201)
746-2177
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