Helsinn reports Phase III CINV data

Helsinn Healthcare S.A. (Pazzallo-Lugano, Switzerland) said a single dose of its oral Netu-palo-FDC (NEPA) plus dexamethasone was superior to a single dose of oral palonosetron plus dexamethasone on the primary endpoint in a Phase III trial to prevent chemotherapy-induced nausea and vomiting (CINV). The primary endpoint of the 1,455-patient NETU-08-18 study was improving complete response rate defined as no emesis and no use of rescue medication 25-120 hours after receiving chemotherapy. Data will be presented at the American Society of Clinical Oncology meeting in June.

Helsinn said it plans to submit an NDA to FDA and MAA to EMA for NEPA to prevent acute and delayed CINV following both highly and moderately emetogenic chemotherapy. The product is a fixed-dose combination of 300 mg netupitant, a neurokinin 1 (NK1) Substance P receptor antagonist, and 0.5 mg palonosetron, a selective serotonin (5-HT3) receptor antagonist. Palonosetron is marketed to prevent CINV under the names Aloxi, Paloxi and Onicit in more than 60 countries worldwide. Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) and Helsinn co-promote Aloxi in the U.S. ...