O-004Selected subgroup analyses of liposomal irinotecan (nal-IRI) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in the global NAPOLI-1 phase III trial

Introduction: NAPOLI1 (NCT01494506; Wang-Gillam et al., Lancet 2016;387:545-57) was a global phase 3 study of patients with mPDAC who progressed following gemcitabine-based therapy. In patients receiving nalIRI+5FU/LV, median overall survival (mOS) was significantly higher (6.1 months) compared with 5FU/LV (4.2 months; unstratified HR = 0.67; P = 0.012). Here, we summarise four separate NAPOLI-1 subgroup analyses investigating the effect of selected baseline parameters.