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Supportive and palliative care

3301 - Phase 3 Safety Evaluation of an Intravenous Formulation of NEPA, a Novel Fixed Antiemetic Combination of Fosnetupitant and Palonosetron

Date

09 Sep 2017

Session

Supportive and palliative care

Topics

Supportive Care and Symptom Management

Presenters

Lee Schwartzberg

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

L. Schwartzberg1, Z. Andric2, D. Kowalski3, D. Voisin4, G. Rizzi5, M. Karthaus6

Author affiliations

  • 1 Hematology & Oncology, West Cancer Center, 38138 - Germantown/US
  • 2 Medical Oncology Department, Clinical Hospital Center Bezanijska Kosa, 11080 - Belgrade/RS
  • 3 Department Of Lung & Thoracic Cancers, The Maria Sklodowska-Curie Memorial Institute and Oncology Centre, 02-781 - Warsaw/PL
  • 4 Clinical Development, Helsinn Healthcare Switzerland, 6912 - Pazzallo - Lugano/CH
  • 5 Statistics & Data Management, Helsinn Healthcare Switzerland, 6912 - Pazzallo - Lugano/CH
  • 6 Department Of Hematology, Oncology, And Palliative Medicine, Klinikum Neuperlach-Staedtisches Klinikum Muenchen, 81737 - Munich/DE
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Resources

Abstract 3301

Background

NEPA, an oral fixed combination of the highly selective NK1RA netupitant (300 mg) and clinically/pharmacologically distinct 5-HT3RA palonosetron (PALO, 0.50 mg) is the first fixed-dose antiemetic combination to have been approved. A single oral NEPA capsule plus dexamethasone (DEX) given prior to AC and non-AC highly emetogenic chemotherapy (HEC) showed superior prevention of chemotherapy-induced nausea and vomiting (CINV) over PALO plus DEX for 5 days post-chemotherapy; the safety of NEPA was also well-established in the Phase 2/3 clinical program in 1442 NEPA-treated patients. An intravenous formulation of the NEPA combination (fosnetupitant 260 mg/PALO 0.25 mg) is under development.

Methods

This randomized, multinational, double-blind, stratified (by gender and country) Phase 3 study in chemotherapy-naïve patients with solid tumors was designed to assess the safety of a single 30-minute infusion of IV NEPA prior to initial and repeated cycles of HEC. Patients received either IV NEPA or oral NEPA, both with oral DEX on days 1-4. Safety was assessed primarily by treatment-emergent adverse events (TEAEs) and also by laboratory tests, vital signs and ECGs.

Results

404 patients were included in the safety population (203 IV NEPA, 201 oral NEPA) for a total of 1312 exposures. Overall, 53% of patients were male, 99% were white and the mean age was 60 years. Cisplatin was the most frequent HEC (96% of patients) and lung cancer was most common (55% of patients). The TEAE profiles for cycle 1 (Table) and in all cycles were similar for the two treatment groups. There was no increased incidence of TEAEs in subsequent cycles. No clinically relevant changes in QTc and no cardiac safety concerns were seen. No infusion site reactions related to IV NEPA occurred.rnTable:

1547PD

rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn
Cycle 1 n (%) patients withIV NEPA (N = 203)Oral NEPA (N = 201)
At least one treatment emergent adverse event (TEAE)120 (59.1%)135 (67.2%)
Severe TEAEs50 (24.6%)51 (25.4%)
Serious TEAE29 (14.3%)21 (10.4%)
Any treatment-related TEAE (TRAE)18 (8.9%)19 (9.5%)
Most common (≥2%) TRAE Constipation10 (4.9%)11 (5.5%)
Serious TRAE00
Any TRAE leading to discontinuation1 (0.5%)0
Any TRAE resulting in death00
rn

Conclusions

Intravenous NEPA was shown to be safe and well-tolerated with a similar safety profile to oral NEPA in patients with various solid tumors receiving HEC.

Clinical trial identification

NCT02517021

Legal entity responsible for the study

Helsinn Healthcare, SA

Funding

Helsinn Healthcare SA

Disclosure

L. Schwartzberg: Served as a consultant for Helsinn, Tesaro, Eisai, and Merck and have received research funding from Helsinn and Tesaro. D. Voisin, G. Rizzi: Employee of Helsinn Healthcare. M. Karthaus: Served as and received honoraria for being a consultant for Helsinn and Riemser. All other authors have declared no conflicts of interest.

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