A Large Phase 3 Study in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed Following Gemcitabine-based Therapy1
RANDOMIZED, OPEN-LABEL CLINICAL TRIAL DESIGN2,3
417 patients randomized across 3 arms
Stratification factors: albumin (<4.0 g/dL vs ≥4.0 g/dL); KPS (70-80 vs 90-100); and ethnicity (Caucasian vs East Asian vs others).2
*Per RECIST v1.1 criteria.3
†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.3
‡In the Phase 3 trial, patients known to be homozygous for the UGT1A1*28 allele were started at ONIVYDE® 50 mg/m2.2
KPS=Karnofsky Performance Status.
- Trial was initiated as a two-arm study and amended after initiation of 63 patients to include a third arm, ONIVYDE® + 5-FU/LV2,3
- Comparisons between the ONIVYDE® + 5-FU/LV and 5-FU/LV arms are limited to patients enrolled in the 5-FU/LV arm after the protocol amendment (n=119)2
- Patients were balanced across a number of demographic and baseline characteristics, including prior number of therapies, age, sex, and site of metastatic disease2,3
- Patients were enrolled at 76 sites in 14 countries across North America, Europe, Asia, South America, and Oceania3
- Treatment continued until disease progression or unacceptable toxicity2
Baseline Demographics and Disease Characteristics of Patients Randomized to ONIVYDE® (irinotecan liposome injection) + 5-FU/LV Arm
|ONIVYDE® + 5-FU/LV & 5-FU/LV Arms Combined
|Age, median years (min, max)||63 (34, 81)|
|Sex, male, %||58|
|Albumin, mean g/dL (SD)||3.97|
|Prior Lines of Metastatic Therapy, %|
§Patients with no prior therapy for metastatic disease were required to have received gemcitabine or gemcitabine-based therapy in the neoadjuvant/adjuvant setting.
Intention-to-treat (ITT) population.
Participants in the NAPOLI-1 Phase 3 clinical study were evenly distributed across a number of demographic and baseline characteristics.
The primary outcome measure was overall survival (OS)2
- OS was evaluated using 2 pair-wise comparisons: ONIVYDE® (irinotecan liposome injection) vs 5-FU/LV and ONIVYDE® + 5-FU/LV vs 5-FU/LV2
Secondary outcome measures included progression-free survival (PFS), objective response rate (ORR), and safety2
- Tumor status assessments were conducted at baseline and every 6 weeks thereafter or sooner if investigator suspected disease progression