New Research on Eribulin Mesylate and Netupitant/Palonosetron to be Presented at Annual San Antonio Breast Cancer Symposium

FOR U.S. MEDIA ONLY

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Dec 01, 2014, 08:00 ET

WOODCLIFF LAKE, N.J., Dec. 1, 2014 /PRNewswire/ -- Eisai announced the presentation of six abstracts at the 2014 San Antonio Breast Cancer Symposium (SABCS), highlighting new data for eribulin mesylate and netupitant/palonosetron (NEPA). The meeting will be held December 9-13, 2014 in San Antonio, Texas.

"The studies presented at this year's SABCS highlight Eisai's ongoing clinical research efforts and reinforce the company's commitment to continued research for patients who are undergoing chemotherapy or affected by locally advanced or metastatic breast cancer," said Kenichi Nomoto, President, Eisai Oncology Product Creation Unit. "Eisai is a human health care company compelled by patient need to pursue insights, via the scientific process, that will further our understanding of these drugs and diseases."

The information discussed in this release presents investigational uses for FDA-approved products. It is not intended to convey conclusions of efficacy or safety.

The following Eisai abstracts are accepted for presentation at this year's San Antonio Breast Cancer Symposium:

Abstract Name

Session

Eribulin Mesylate Abstracts

Efficacy of Eribulin in Patients with Invasive Lobular
Carcinoma of the Breast: Data from a Pooled Analysis

This exploratory pooled analysis evaluated patients from the
experimental arms of two Phase III studies and a single-arm,
Phase II study to evaluate the efficacy of eribulin in patients
with advanced invasive lobular carcinoma of the breast.

P3-13-04

J. Cortes

Efficacy and Safety of Eribulin in Combination with
Capecitabine in Patients with Metastatic Breast Cancer: An
Open-Label, Phase 2 Dose-Confirmation Study

The aim of this open-label, non-randomized, Phase II,
dose-confirmation study was to determine efficacy and
safety of eribulin in combination with capecitabine in patients
with metastatic breast cancer.

P3-13-06

J. Evans

Quality of Life Results from a Phase 2, Multicenter,
Single-Arm Study of Eribulin Mesylate Plus Trastuzumab as
First-Line Therapy for Locally Recurrent or Metastatic
HER2+ Breast Cancer

This Phase II, single-arm study evaluated quality of life,
efficacy and safety/tolerability of eribulin mesylate plus
trastuzumab as a first-line therapy for locally recurrent or metastatic
HER2-positive breast cancer.

P5-17-03

L. Schwartzberg

Quality of Life in Patients Receiving First-Line Eribulin
Mesylate for HER2- Locally Recurrent or MBC

This Phase II study evaluated quality of life in patients
receiving first-line eribulin mesylate for the treatment of
HER2-negative locally recurrent or metastatic breast cancer.

P5-17-02

L. Schwartzberg

Eribulin Mesylate Plus Capecitabine for Adjuvant Treatment
in Post-Menopausal ER+ Early-stage Breast Cancer: A
Phase 2, Multicenter, Open-Label Study Using 2 Different
Dosage Regimens

The primary objective of this Phase 2 study was to explore
the feasibility of administering eribulin plus capecitabine as
adjuvant therapy in subjects with early-stage, estrogen
receptor-positive (ER+) breast cancer.

P3-09-09

J.W. Smith II

NEPA Abstract

Evaluation of Sustained Antiemetic Efficacy Over Repeated
Cycles of Anthracycline-Cyclophosphamide (AC)-Based
Chemotherapy: A Phase 3 Study of NEPA, a Fixed-Dose
Combination of Netupitant and Palonosetron for Prevention
of Chemotherapy-Induced Nausea and Vomiting (CINV)

This post hoc analysis evaluates the antiemetic efficacy of
netupitant and palonosetron over repeated cycles of
anthracycline/cyclophosphamide-based chemotherapy
when censoring patients who experienced CINV in a
previous cycle of chemotherapy.

P5-15-01

M. Aapro

About Halaven^® (eribulin mesylate) Injection
Eribulin mesylate injection (available as Halaven^®) is indicated for patients with metastatic breast cancer who have received at least two other types of anticancer medicines for their breast cancer once it has spread to other parts of the body. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer. Eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. 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.

Halaven 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 HALAVEN. 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 HALAVEN. Delay administration of HALAVEN 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

HALAVEN 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 HALAVEN 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 (CrCl 30-50 mL/min) renal impairment, a reduction in starting dose is recommended

Most Common Adverse Reactions

Most common adverse reactions (greater than or equal to 25%) reported in patients receiving HALAVEN 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 HALAVEN were febrile neutropenia (4%) and neutropenia (2%)

HALAVEN is available by prescription only.

For more information about HALAVEN, click here for the full Product Information or visit www.HALAVEN.com.

About AKYNZEO^® (netupitant/palonosetron) Capsules
AKYNZEO is an oral fixed combination of netupitant, a substance P/neurokinin 1 (NK₁) receptor antagonist, and palonosetron, a serotonin-3 (5-HT₃) receptor antagonist indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO targets two critical signalling pathways associated with chemotherapy-induced nausea and vomiting (CINV).

AKYNZEO Important Safety Information

Warning and Precautions

Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT₃ receptor antagonists
Serotonin syndrome has been reported with 5-HT₃ receptor antagonists alone but particularly with the use of serotonergic drugs. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment

Adverse Reactions

Most common adverse reactions (greater than or equal to 3% and greater than palonosetron): headache, asthenia, dyspepsia, fatigue, constipation and erythema

Drug Interactions

Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The inhibitory effect on CYP3A4 can last for multiple days
- Dexamethasone doses should be reduced when given with AKYNZEO
- Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO
- Caution and monitoring for chemotherapy-related adverse events are advised in patients receiving chemotherapy agents metabolized primarily by CYP3A4 including docetaxel, paclitaxel, etoposide, irinotecan, cyclophosphamide, ifosfamide, imatinib, vinorelbine, vinblastine, and vincristine
Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO

Use in Specific Populations

Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end stage renal disease

AKYNZEO is available by prescription only.

For more information about AKYNZEO, click here for the full Product Information or visit www.AKYNZEO.com.

About Helsinn and Eisai
Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for AKYNZEO in the United States. Under the terms of the agreement, Helsinn is responsible for conducting all development activities (Chemistry and Manufacturing Controls [CMC], preclinical and clinical), obtaining regulatory approvals and holding the New Drug Application (NDA). AKYNZEO is promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. subsidiary of Helsinn.

About the Helsinn Group
Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn's products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.

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.