MO2-3 Nal-IRI+5-FU/LV vs 5-FU/LV in metastatic pancreatic cancer – Additional safety report of randomized Japanese phase 2 trial

Abstract

A phase II study was conducted in Japanese patients with pancreatic cancer who had metastases after chemotherapy containing gemcitabine (NCT02697058). Based on the results of this study and a global phase III randomized open-label trial, nal-IRI obtained market authorization in March 2020 for the indication of “Unresectable pancreatic cancer after disease progression following cancer chemotherapy”. The purpose of this report is to explore nal-IRI safety profile in Japanese patients since limited post marketing data is available.