Preliminary findings demonstrate intravenous NEPA to be safe and well-tolerated, with a similar safety profile to oral NEPA
Lugano, Switzerland, September 6, 2017 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, today announces that data on the new investigational intravenous formulation of NEPA, a fixed antiemetic combination of fosnetupitant, 235mg, and palonosetron, 0.25mg, will be presented at the European Society for Medical Oncology (ESMO) Congress in September 2017.
The Phase III safety study data revealed Intravenous NEPA to be safe and well-tolerated with a similar safety profile to oral NEPA in patients with various solid tumors receiving highly-emetogenic chemotherapy (HEC).
This randomized, multinational, double-blind, stratified (by gender and country) Phase III study in chemotherapy-naïve patients with solid tumors was designed to assess the safety of a single 30-minute infusion of IV NEPA prior to initial and repeated cycles of HEC. Patients received either IV NEPA or oral NEPA, in combination with oral DEX on days 1-4. Safety was assessed primarily by treatment-emergent adverse events (TEAEs) and also by laboratory tests, vital signs and ECGs.
404 patients were included in the safety population (203 IV NEPA, 201 oral NEPA) for a total of 1312 exposures. Overall, 53% of patients were male, 99% were white and the mean age was 60 years. Cisplatin was the most frequent HEC (96% of patients) and lung cancer was most common (55% of patients). The TEAE profiles for cycle 1 and in all cycles were similar for the two treatment groups. There was no increased incidence of TEAEs in subsequent cycles. No clinically relevant changes in QTc and no cardiac safety concerns were observed. No infusion site reactions related to IV NEPA occurred.
L. Schwartzberg, Hematology & Oncology, West Cancer Center, Germantown, TN, the author of the study, commented: “These data establish that the IV formulation of NEPA, has a safety and tolerability profile that is similar to the approved oral NEPA formulation.”
Sergio Cantoreggi, Helsinn Group Chief Scientific Officer, added:“At Helsinn we are committed to building quality cancer care together and make treatment decisions easier for clinicians. We are delighted that the IV formulation of NEPA data have been accepted for presentation at the ESMO 2017 Congress. The benefits offered by NEPA as an anti-emetic administered orally are well established as NEPA is currently recommended by various major antiemetic guidelines.”
A New Drug Application (NDA) for IV NEPA has been accepted by the US Food and Drug Administration (FDA). Helsinn’s NDA is supported by data from several clinical studies focused on the safety and pharmacokinetics of the drug in the prevention of CINV following highly emetogenic chemotherapy.
- Title: Phase 3 Safety Evaluation of an Intravenous Formulation of NEPA, a Novel Fixed Antiemetic Combination of Fosnetupitant and Palonosetron
- Author: L. Schwartzberg, Z. Andric, D. Kowalski, D. Voisin, G. Rizzi, M. Karthaus
- Abstract number: 1547PD
- Session title: Supportive and palliative care
- Date, time and location: Saturday, September 9th, 09:15 – 10:45, Bilbao Auditorium
ESMO 2017 will be held from 8-12 September 2017 in Madrid, Spain. Further details can be found here: http://www.esmo.org/Conferences/ESMO-2017-Congress
About NEPA (netupitant/palonosetron)
In the EU:
Akynzeo® (netupitant 300mg/palonosetron 0.5mg) capsules for oral use was approved in May 2015 in the EU. Akynzeo oral is indicated in the EU for adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.
For additional information please see the EU Summary of Product Characteristics
In the US:
Akynzeo® (netupitant 300mg/palonosetron 0.5mg) capsules for oral use was approved in October 2014 in the United States 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® is an oral fixed combination of palonosetron and netupitant. Palonosetron, a 5HT3 inhibitor, prevents nausea and vomiting during the acute phase and netupitant, an NK-1 inhibitor, prevents nausea and vomiting during both the acute and delayed phases after cancer chemotherapy.
NEPA has been recommended by various antiemetic guidelines: the National Comprehensive Cancer Network (NCCN) antiemetic guidelines, both in Highly Emetogenic Chemotherapy ( HEC; inclusive of AC and carboplatin AUC≥4)) and Moderately Emetogenic Chemotherapy (MEC); the American Society for Clinical Oncology (ASCO) guideline for antiemetics in oncology, in HEC AC and carboplatin (AUC≥4) regimens and the MASCC/ESMO Guidelines in HEC, AC and carboplatin based chemotherapy. Helsinn currently has 20 licensing partners for Akynzeo® in 167 countries.
The fixed combination of an intravenous formulation of NEPA is currently under FDA evaluation before it can be put in the market.
Important Safety Information about Akynzeo®
Warnings 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 concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. 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. Patients should be informed of the increased risk of serotonin syndrome, especially if Akynzeo® is used concomitantly with other serotonergic drugs.
- Most common adverse reactions: headache, asthenia, dyspepsia, fatigue, constipation and erythema
- Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with Akynzeo®. The inhibitory effect on CYP3A4 can last for multiple days
- Dexamethasone doses should be reduced when given with Akynzeo®. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant.
- Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with Akynzeo®. When administered with netupitant, the systemic exposure to midazolam was significantly increased.
- 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
For additional information please see the US full Prescribing Information for Akynzeo.
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland and the U.S., a representative office in China as well as a product presence in approximately 190 countries globally.
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