Abstract P2-12-04: Efficacy of intravenous (IV) NEPA and oral NEPA, fixed NK1/5-HT3 receptor antagonist (RA) combination agents, for prevention of chemotherapy-induced nausea and vomiting (CINV) following anthracycline-cyclophosphamide (AC)-based chemotherapy

Abstract

Abstract Background: The antiemetic guideline-based standard of care for prevention of CINV in patients receiving AC-based chemotherapy is the combination of an NK1 RA, a 5-HT3 RA, and dexamethasone (DEX). An IV formulation of NEPA (fixed combination of the NK1 RA, fosnetupitant and 5-HT3 RA, palonosetron) was recently approved in the United States. Two studies were completed in patients receiving cisplatin (Phase 3) or AC (Phase 3b) to assess the safety of IV NEPA, with specific attention paid to injection-site/hypersensitivity reactions as such events have occurred with other NK1 RAs, particularly in the AC setting. No treatment-related injection-site reactions were reported in >1300 infusions of IV NEPA. Oral NEPA was previously shown to be superior to palonosetron in a Phase 3 AC study. This analysis presents the efficacy data of IV NEPA and oral NEPA in the AC setting. Methods: Data is compiled from the IV NEPA Phase 3b study as well as from an oral NEPA registration study in females with breast cancer undergoing AC-based chemotherapy. IV NEPA was administered as a single 30-minute infusion and oral NEPA was given as a single capsule 60 minutes prior to AC. Patients also received DEX prior to AC on Day 1 only. Complete response (CR: no emesis/no rescue medication) rates are summarized for the acute (Day 1), delayed (Days 2-5) and overall (Days 1-5) phases of Cycle 1 for each treatment/study and also pooled for oral NEPA across the 2 studies. No formal statistical comparisons were performed. Results: Patient characteristics were similar in both studies. CR rates were comparable for IV NEPA and oral NEPA in the individual studies as well as with oral NEPA when pooled across the 2 studies (Table). Cycle 1 Complete Response IV NEPA StudyOral NEPA Study Pooled Studies % Patients IV NEPAOral NEPAOral NEPAOral NEPA(N = 200)(N = 202)(N = 708)(N = 910)Acute (0-24 h)86.588.688.388.4Delayed (25-120 h)75.578.776.476.9Overall (0-120 h)73.077.273.974.6 Conclusions: Both IV and oral formulations of NEPA in combination with DEX represent guideline-compliant single-dose antiemetic agents that are highly effective over 5 days in patients receiving AC-based chemotherapy. Citation Format: Matti Aapro, Lee Schwartzberg. Efficacy of intravenous (IV) NEPA and oral NEPA, fixed NK1/5-HT3 receptor antagonist (RA) combination agents, for prevention of chemotherapy-induced nausea and vomiting (CINV) following anthracycline-cyclophosphamide (AC)-based chemotherapy [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-12-04.