Abstract
122 Background: NEPA is an oral fixed combination of the selective NK1 receptor antagonist (RA), netupitant (300 mg), and pharmacologically distinct 5-HT3RA, palonosetron (PALO 0.50 mg), combining two guideline-recommended antiemetic classes in a convenient single capsule. Oral NEPA has shown superior prevention of chemotherapy-induced nausea and vomiting (CINV) over oral PALO, sustained efficacy over multiple cycles, and well-established safety in >1500 patients (pts). To offer additional convenience for health care practitioners and pts, an intravenous (IV) formulation of the NEPA fixed combination (fosnetupitant 235 mg/PALO 0.25 mg) was developed. Methods: This randomized, multinational, double-blind, stratified (by gender/country) phase 3 study in chemotherapy-naïve pts with solid tumors was designed to assess the safety of a single 30-minute infusion of IV NEPA prior to initial/up to 4 repeated cycles of highly emetogenic chemotherapy (HEC). Patients received either IV NEPA or oral NEPA, both with oral dexamethasone on days 1-4. Safety was assessed by treatment-emergent adverse events (TEAEs), laboratory tests, vital signs and ECGs. Results: 404 pts were evaluated for a total of 1312 exposures. Overall, 53% of pts were male with a mean age of 60 years; 99% of pts were white and cisplatin-containing regimen was the HEC for 96% of pts; lung cancer was the most common tumor (55% pts). The AE profiles were similar for both groups in cycle 1 and across all cycles (See Table), with no increased incidence of AEs in subsequent cycles. No infusion site reactions related to IV NEPA occurred. No clinically relevant changes in QTcor cardiac safety concerns were observed. Conclusions: IV NEPA is safe and well-tolerated over multiple cycles with a similar safety profile to oral NEPA in pts receiving HEC. Clinical trial information: NCT02517021. [Table: see text]
Published Version
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