Helsinn Group presents phase III data in NEPA at MASCC/ISOO Congress
Helsinn, a Swiss pharmaceutical group focused on building quality cancer care products, has announced that data showing the non-inferiority of NEPA (netupitant/palonestron) versus a 3-day oral aprepitant (APR)/granisetron (GRAN) regimen, have been accepted for presentation at the upcoming Multinational Association of Supportive Care in Cancer (MASCC/ISOO) Congress, on June 22-24 2017.
NEPA is the first fixed combination of the selective NK1RA, netupitant (300 mg), and the clinically and pharmacologically active 5-HT3RA, palonosetron (0.5mg) for the prevention of CINV, in a convenient single capsule.
This randomized, double-blind, Phase 3 study conducted in 828 chemotherapy-naïve Asian patients receiving cisplatin-based emetogenic chemotherapy (HEC) agents, is the first head to head study comparing NK1RA regimens. Patients received a single oral dose of NEPA on day 1 or a 3-day oral APR/GRAN regimen (days 1-3). All patients received oral dexamethasone on days 1-4. The primary efficacy endpoint was complete response (CR: no emesis/rescue medication) during the overall (0-120h) phase. Non-inferiority was defined as a lower 95% CI greater than the non-inferiority margin set at -10%. Secondary endpoints included no emesis no rescue medication and no significant nausea (NSN: <25mm on 100mm VAS).
For the primary efficacy endpoint of overall CR, NEPA on day 1 was non-inferior to 3-day oral APR/GRAN regimen with a comparable safety profile. In addition the daily CINV events (emesis and/or rescue medication use) declined numerically over time with NEPA reaching the statistical significance at day 5 compared to APR/GRAN arm suggesting a benefit for delayed CINV.