WOODCLIFF LAKE, New Jersey, and LUGANO, Switzerland, June 26, 2014 /PRNewswire/ --
Eisai Inc. and Helsinn Group announced today that several abstracts highlighting data analyses of NEPA, an investigational oral fixed-dose combination of netupitant and palonosetron being evaluated for the prevention of chemotherapy-induced nausea and vomiting (CINV), will be presented at the International Symposium on Supportive Care in Cancer. The Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) will host this year's Symposium in Miami, Florida.
"There is a need to study a new option for chemotherapy-induced nausea and vomiting prevention, despite the progress that has been made thus far," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. "Further exemplifying our human health care mission, Eisai is committed to the continued study of NEPA in order to better understand its potential benefit for patients who experience these common side effects of chemotherapy."[1]
Riccardo Braglia, Helsinn's Group Chief Executive Officer, commented: "Chemotherapy-induced nausea and vomiting is one of the most common side effects following cancer treatments.[1] Helsinn is committed to addressing these symptoms and looks forward to presenting, alongside Eisai, the latest clinical data on NEPA."
In addition to the NEPA abstracts, three abstracts from Eisai's Health Economics and Outcomes Research group will also be presented, for a total of seven oral presentations and one poster presentation.
The following abstracts have been accepted for presentation at this year's MASCC/ISOO Symposium:
Abstract Name/Description Session
NEPA Abstracts
Multiple Cycle CINV Control and Safety of NEPA, a Capsule PL03 Plenary Session
Containing Netupitant and Palonosetron Administered Once M. Aapro
per Cycle of Moderately Emetogenic Chemotherapy (MEC)
The aim of this prospective analysis was to assess
maintenance of efficacy and safety across continued cycles
in this randomized, double-blind Phase 3 study of NEPA
versus oral palonosetron in chemotherapy-naïve patients
receiving multiple cycles of
anthracycline-cyclophosphamide.[2]
NEPA, a Fixed-Dose Antiemetic Combination of Netupitant PS03 Parallel Session
and Palonosetron: Results of Effectiveness in 407 Patients P. J. Hesketh
Receiving Cisplatin Plus Chemotherapy of Various Emetic
Risk
This retrospective study analyzed results of a completed,
double-blind NEPA study to determine if emetic prevention
differed by the chemotherapy added to cisplatin.[3]
Do NK1 Receptor Antagonists (RA) Contribute to Nausea PS03 Parallel Session
Control? Evaluation of the Novel NEPA Fixed-Dose L. Schwartzberg
Combination of NK1 RA + 5-HT3 RA from Pivotal Trials
This pooled analysis evaluated patients from two
randomized, multinational studies to evaluate nausea
control in patients receiving NEPA plus dexamethasone
compared with single-agent oral palonosetron plus
dexamethasone.[4]
Is the Addition of an NK1 Receptor Antagonist Beneficial PS03 Parallel Session
in Patients Receiving Carboplatin? Supplementary Data with K. Jordan
NEPA, a Fixed-Dose Combination of Netupitant and
Palonosetron
This post-hoc analysis from a prospective Phase 3 trial
evaluated the effectiveness of a single oral dose of NEPA
plus dexamethasone in chemotherapy-naïve patients
receiving repeated carboplatin cycles.[5]
Safety of NEPA, an Oral Fixed-Dose Combination of PO18 Poster Session
Netupitant and Palonosetron: Pooled Data from the Phase Poster Number: 142
2/3 Clinical Program M. Aapro
This pooled analysis evaluated adverse event data for
3,280 patients who participated in four randomized,
double-blind, multinational NEPA clinical trials.[6]
Eisai Oncology Health Economics and Outcomes Abstracts
Comparing the Incidence of Chemotherapy Induced Nausea and PS03 Parallel Session
Vomiting Following 5HT3RA and NK1 Antiemetic Prophylaxis R. Knoth
This retrospective cohort analysis compared the incidence
of CINV in patients undergoing chemotherapy and treated
prophylactically with either intravenous (IV) palonosetron
alone or other 5HT3RAs in combination with an IV or oral
neurokinin 1 receptor antagonist (NK1).
Comparing the Cost of Chemotherapy Induced Nausea and PS07 Parallel Session
Vomiting Following 5HT3RA and NK1 Antiemetic Prophylaxis R. Knoth
This study compared CINV-related costs in patients
undergoing chemotherapy and treated prophylactically with
either IV palonosetron alone vs. other 5HT3RAs in
combination with an IV or oral neurokinin 1 receptor
antagonist (NK1).
Resource Utilization and Costs Associated with Nausea in PS07 Parallel Session
Patients Experiencing Chemotherapy-Induced Nausea and C. Faria
Vomiting
The goal of this retrospective analysis of insurance
claims from 2005-2011 was to evaluate the implications of
nausea alone on resource utilization and costs.[7]
The information discussed in this release presents an investigational agent that is not Food and Drug Administration (FDA)-approved. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that this investigational agent will successfully gain FDA approval.
About Netupitant 300 mg + Palonosetron 0.50 mg (NEPA)
NEPA is an investigational oral, fixed-dose combination of a NK1 receptor antagonist, netupitant, and a 5-HT3 receptor antagonist, palonosetron, believed to target two critical signaling pathways associated with chemotherapy-induced nausea and vomiting (CINV).[8]
On December 9, 2013, the U.S. Food and Drug Administration (FDA) accepted for review the submission of Helsinn's New Drug Application (NDA) for NEPA. Acceptance of the NDA indicates that the FDA has found the submission to be sufficiently complete to review.
On January 22, 2014, the European Medicines Agency (EMA) accepted for review the submission of Helsinn's Marketing Authorisation Application for the prevention of acute and delayed CINV. Acceptance of the MAA indicates that the EMA has found the submission to be valid for review.
About Helsinn and Eisai
Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for NEPA in the United States (if approved). 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). If approved by the FDA, NEPA will be co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. subsidiary of Helsinn.
About the Helsinn Group
(CONTINUA)
