Treatment continued until disease progression or unacceptable toxicity1
Primary endpoint: OS1
OS was evaluated using 2 pair-wise comparisons: ONIVYDE® vs 5-FU/LV and ONIVYDE® + 5-FU/LV vs 5-FU/LV
The comparisons between the ONIVYDE® + 5-FU/LV and the 5-FU/LV arms are limited to patients enrolled in the 5-FU/LV arm after the protocol amendment (n=119)
Secondary endpoints: PFS, ORR, and safety1,4
Tumor status assessments were conducted at baseline and every 6 weeks thereafter or sooner if investigator suspected disease progression
*Study was amended to add the ONIVYDE® + 5-FU/LV arm once safety data on the combination became available; 63 patients already had been enrolled in the original 2-arm study at the time of amendment.1,2
†The disease must have progressed after previous gemcitabine-based therapy given in a neoadjuvant, adjuvant (only if distant metastases occurred within 6 months of completing adjuvant therapy), locally advanced, or metastatic setting.2
IV=intravenous; KPS=Karnofsky performance status.
Most patients were treated in 1st & 2nd line metastatic pancreatic cancer after gemcitabine1,2
NAPOLI-1: Patient characteristics
Baseline demographics and disease characteristics of patients randomized to ONIVYDE® + 5-FU/LV arms combined2,4
ONIVYDE® + 5-FU/LV n=117
Sex, male %
Albumin, mean g/dL (SD)
PRIOR LINES OF METASTATIC THERAPY, %
ONIVYDE® + 5-FU/LV is approved for use after gemcitabine-based treatment in METASTATIC PANCREATIC CANCER1
Participants in NAPOLI-1 were evenly distributed across a number of demographic and baseline characteristics, including prior number of therapies, age, sex, and site of metastatic disease1
Patients were enrolled at 76 sites in 14 countries across North America, Europe, Asia, South America, and Oceania2
‡5-FU/LV control group based on protocol version 2.
§Baseline KPS score was missing for one patient in the 5-FU/LV group (enrolled under protocol 2) who was subsequently stratified as having a score ≥90.
||Patients with no prior therapy for metastatic disease were required to have received gemcitabine or gemcitabine-based therapy in the neoadjuvant/adjuvant setting.