Efficacy and safety studied in global phase 3 clinical trial2,4

NAPOLI-1: The largest phase 3 trial in patients with metastatic pancreatic cancer with disease progression after gemcitabine-based therapy2,4

Study Design Chart
Study Design Chart
  • 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=1175-FU/LV n=119
Age, years63 (57-70)62 (55-69)
Sex, male %5956
Albumin, mean g/dL (SD)3.97 (0.46)3.98 (0.51)
KPS§, %
East Asian2930
African American/Black33
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.

KPS=Karnofsky performance status; SD=standard deviation.