Abstract 920
Background
The antiemetic standard of care recommended by guidelines for prevention of CINV in patients receiving cisplatin- and AC-based CT 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 US and is under review in Europe. Approval of IV NEPA was based on showing pharmacokinetic bioequivalence of IV fosnetupitant to oral netupitant and similar safety of IV NEPA to oral NEPA in a phase III study in patients receiving cisplatin-based CT. An IV/oral NEPA safety-controlled phase IIIb study was recently completed in patients receiving AC CT. In both studies, there were no injection-site or hypersensitivity reactions associated with IV NEPA. This secondary analysis presents the efficacy of IV NEPA relative to that of oral NEPA and other NK1 RAs in cisplatin and AC settings.
Methods
Data is compiled from 5 pivotal NEPA studies in a total of 2077 adult chemotherapy-naïve patients with solid tumors undergoing either cisplatin- or AC-based CT. IV NEPA was administered as a single 30-min infusion; oral NEPA was given as a single capsule 60 min prior to CT. Patients also received DEX. Data was also reviewed from 9 phase III cisplatin and AC studies with other NK1 RA (aprepitant [APR], fosaprepitant [FOS], rolapitant [ROL]) regimens. No emesis rates are summarized for the overall phase (0-120h) of the initial cycle of CT. No formal statistical comparisons were performed.
Results
The overall no emesis rates of > 80% for IV NEPA were similar to oral NEPA in both cisplatin and AC settings and were favorable in the context of historical NK1 RA regimens.Table:
1765P
Setting/Study | IV NEPA + DEX | Oral NEPA + DEX | APR + 5-HT3RA + DEX | FOS + 5-HT3RA + DEX | ROL + 5-HT3RA + DEX |
---|---|---|---|---|---|
Cisplatin | |||||
Schwartzberg 2018 | 84.2% | 88.6% | - | - | |
Hesketh 2014 | - | 91.1% | - | - | |
Zhang 2018 | - | 75.0% | - | - | |
Grunberg 2011 | - | - | 74.6% | 72.9% | |
Hesketh 2003 | - | - | 77.7% | - | - |
Poli-Bigelli 2003 | - | - | 66% | - | - |
Schmoll 2006 | - | - | 76.5% | - | - |
Saito 2013 | - | - | - | 67.6% | - |
Rapoport 2015 (HEC-1) | - | - | - | - | 75% |
Rapoport 2015 (HEC-2) | - | - | - | - | 71% |
AC | |||||
Schwartzberg 2019 | 82.5% | 86.1% | - | - | - |
Aapro 2014 | - | 79.8% | - | - | - |
Warr 2005 | - | - | 76% | - | - |
Schwartzberg 2016 | - | - | - | - | 72.4% |
Conclusions
Both IV and oral formulations of NEPA along with DEX represent highly effective guideline-compliant single-dose antiemetics.
Clinical trial identification
NCT03403712.
Editorial acknowledgement
Jennifer Vanden Burgt, Minneapolis, MN, funded by Helsinn Healthcare, Lugano, Switzerland.
Legal entity responsible for the study
Helsinn Healthcare.
Funding
Helsinn Healthcare.
Disclosure
L. Schwartzberg: Advisory / Consultancy, Research grant / Funding (institution): Helsinn Healthcare ; Advisory / Consultancy, Research grant / Funding (institution): Tesaro; Advisory / Consultancy: Merck ; Advisory / Consultancy: Heron. M.S. Aapro: Advisory / Consultancy, Research grant / Funding (institution): Helsinn Healthcare; Advisory / Consultancy: Mundipharma; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Merck; Advisory / Consultancy: G1 Therapeutics.
Resources from the same session
4325 - Multiple synchronous mechanisms may contribute to osimertinib resistance in non-small cell lung cancer (NSCLC) patients: insights of the MATCH-R study
Presenter: Diego Enrico
Session: Poster Display session 1
Resources:
Abstract
2185 - Sequential treatment with afatinib followed by 3rd generation EGFR-TKI – subgroup analysis of the GIDEON trial: a prospective non-interventional study (NIS) in EGFR mutated NSCLC patients in Germany
Presenter: Wolfgang Brückl
Session: Poster Display session 1
Resources:
Abstract
1524 - Effectiveness of sequencing TKIs in patients with EGFR mutation-positive Non-small-Cell Lung Cancer (NSCLC): A French National medico administrative claim database analysis
Presenter: Nicolas Girard
Session: Poster Display session 1
Resources:
Abstract
5733 - Phase II study of osimertinib in NSCLC patients with EGFR exon 20 insertion mutation: A multicenter trial of the Korean Cancer Study Group (LU17-19)
Presenter: Tae Min Kim
Session: Poster Display session 1
Resources:
Abstract
5440 - Different stories for different EGFR exon 19 deletion variants
Presenter: Chao Zhao
Session: Poster Display session 1
Resources:
Abstract
2982 - Safety and activity of alflutinib in patients with advanced EGFR T790M mutation non-small cell lung cancer who progressed after EGFR-TKI therapy
Presenter: Yuan-Kai Shi
Session: Poster Display session 1
Resources:
Abstract
4002 - Afatinib followed by osimertinib in patients with EGFR mutation-positive (EGFRm+) advanced NSCLC: updated data from the GioTag real-world study
Presenter: Maximilian Hochmair
Session: Poster Display session 1
Resources:
Abstract
2941 - Treatment patterns of EGFR mt+ NSCLC IV pts: Real world data of the NOWEL network
Presenter: Julia Roeper
Session: Poster Display session 1
Resources:
Abstract
4154 - TP53 mutations predicts worse prognosis in EGFR-mutated NSCLC patients receiving TKIs in first- or further line of treatment
Presenter: Matteo Canale
Session: Poster Display session 1
Resources:
Abstract
1175 - HER3 ligand heregulin expression and clinical implication in patients with epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer treated with EGFR-tyrosine kinase inhibitors
Presenter: Kimio Yonesaka
Session: Poster Display session 1
Resources:
Abstract