Antiemetic efficacy of intravenous (IV) NEPA in patients with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy.

Abstract

115 Background: The complexity of administering multi-agent prophylactic antiemetic combinations required to prevent chemotherapy-induced nausea and vomiting (CINV) may contribute to poor guideline adherence seen in multiple studies. NEPA, a combination antiemetic of an NK1 receptor antagonist (RA) [netupitant (oral)/fosnetupitant (IV)] and 5-HT3RA, palonosetron, offers 5-day CINV prevention with a single dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients, thereby minimizing infusion-related toxicities that have been reported with other NK1RAs. This study previously reported the safety of IV NEPA in BC patients receiving repeat cycles of AC; there were no infusion-site or hypersensitivity reactions related to IV NEPA reported. The efficacy results of this study are the focus of this presentation. Methods: This was a Phase 3b, double-blind safety study in females with BC naïve to highly/moderately emetogenic chemotherapy. Patients were randomized 1:1 to receive a single 30-min infusion of IV NEPA or a single oral NEPA capsule on Day 1 prior to AC. Oral dexamethasone was also given to all patients before AC on Day 1 only. Complete response (CR: no emesis, no rescue) and no significant nausea (NSN: < 25mm on 100mm VAS scale) rates were calculated daily during the 5 days (0-120 h) post-AC in Cycle 1. No formal statistical comparison between groups was planned. Results: 402 total patients were included in the analysis. Most patients were white (93%) with ECOG status of 0 (75%); the mean age was 55 years. Comparable CR and NSN rates were seen for IV and oral NEPA during each of the 5 days post-AC. Conclusions: As a simplified single-dose formulation, IV NEPA showed high response rates in BC patients receiving AC, with favorable safety as no treatment-related infusion-site/hypersensitivity reactions were reported. Clinical trial information: NCT03403712. [Table: see text]