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NAPOLI 3

NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive metastatic pancreatic ductal adenocarcinoma (NAPOLI 3)

Phase 3N = 770NCT04083235

Population
Treatment-naive metastatic pancreatic ductal adenocarcinoma, ECOG 0 or 1
Design
Randomised (1:1), open-label phase 3 trial at 187 sites in 18 countries: NALIRIFOX (liposomal irinotecan, oxaliplatin, leucovorin, fluorouracil; days 1 and 15 of a 28-day cycle) versus nab-paclitaxel plus gemcitabine (days 1, 8, 15), ECOG performance status 0 or 1. Primary endpoint overall survival in the intention-to-treat population.
Primary endpoint
OS
Arms
  • NALIRIFOX (experimental, n = 383): Liposomal irinotecan 50 mg/m2, oxaliplatin 60 mg/m2, leucovorin 400 mg/m2, fluorouracil 2400 mg/m2 over 46 hours, days 1 and 15 of a 28-day cycle
  • Nab-paclitaxel plus gemcitabine (control, n = 387): Nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2, days 1, 8, 15 of a 28-day cycle
People
Wainberg ZA
OSHR 0.83 (95% CI 0.70–0.99)Δ median OS+1.9 months
Show the numbers
Results reported for NAPOLI 3
EndpointAnalysisNALIRIFOXNab-paclitaxel plus gemcitabineEffect
OSprimarymedian follow-up 16.1 monthsWainberg 2023median 11.1 months (10.0–12.1)median 9.2 months (8.3–10.6)HR 0.83 (95% CI 0.70–0.99)P=0.036
Results reported for NAPOLI 3
EndpointAnalysisNALIRIFOXNab-paclitaxel plus gemcitabineEffect
OSprimarymedian follow-up 16.1 monthsWainberg 2023median 11.1 months (10.0–12.1)median 9.2 months (8.3–10.6)HR 0.83 (95% CI 0.70–0.99)P=0.036
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.830.7–0.99
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • NALIRIFOX (experimental)
  • Nab-paclitaxel plus gemcitabine (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsNALIRIFOXNab-paclitaxel plus gemcitabine
0100.0%100.0%
764.6%59.0%
1441.7%34.8%
2126.9%20.6%
2817.4%12.1%
Primary publication: Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardière C, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023;402(10409):1272-1281. PubMedDOI

Appears in

Sources

  1. Wainberg ZA, Melisi D, Macarulla T, Pazo Cid R, Chandana SR, De La Fouchardière C, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023;402(10409):1272-1281.

    PubMedDOI