KEY TAKEAWAYS
- The NAPOLI 3 phase 3 trial aimed to investigate the efficacy of NALIRIFOX versus Gem+NabP in elderly patients with untreated mPDAC.
- The primary endpoint was to determine mOS.
- Researchers concluded that NALIRIFOX demonstrates consistent efficacy, affirming its suitability.
In NAPOLI 3 (NCT04083235), a global, randomized, open-label phase 3 study, NALIRIFOX significantly improved median overall survival (mOS; primary endpoint) and median progression-free survival (mPFS) compared to Gem+NabP in patients untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) aged 65.0 years (range: 20–85). Despite mPDAC’s prevalence among those aged 65–70, older patients are often underrepresented in trials and may lack treatment options.
Teresa Macarulla Mercade and the team aimed to assess the efficacy and safety of NALIRIFOX compared to Gem+NabP in these older patient subgroups.
They performed an inclusive analysis, randomizing eligible patients with untreated mPDAC in NAPOLI 3. They compared liposomal irinotecan 50 mg/m2 + oxaliplatin 60 mg/m2 + leucovorin 400 mg/m2 + 5-fluorouracil 2400 mg/m2 (NALIRIFOX) on days 1 and 15 of a 28-day cycle vs nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 (Gem+NabP) on days 1, 8, and 15 of a 28-day cycle. Efficacy and safety analyses were conducted in the intent-to-treat (ITT) and safety populations, respectively, using Kaplan–Meier methods for time-to-event endpoints.
About 50.1% and 28.2% of the 770 randomized patients in NAPOLI 3 were aged ≥ 65 years and ≥ 70 years, respectively. Baseline characteristics were generally balanced. OS and PFS outcomes showed numerical improvements with NALIRIFOX compared to Gem+NabP in both age subgroups. In the NALIRIFOX and Gem+NabP groups (safety population), similar proportions of patients received subsequent anticancer therapy (50.8% vs 52.6% for ≥ 65 years; 44.7% vs 47.7% for ≥ 70 years).
The study concluded that outcomes in patients aged ≥ 65 years and ≥ 70 years were consistent with those of the overall NAPOLI 3 population, supporting NALIRIFOX as a viable treatment option for older patients. Caution is advised in interpreting results due to limited patient numbers.
The trial was sponsored by Ipsen.
Source: https://cslide.ctimeetingtech.com/esmogi24hybrid/attendee/confcal/show/session/3
Clinical Trial: https://clinicaltrials.gov/study/NCT04083235
Mercade T.M., Cid R.A.P., Womack M, et al. (2024). “NALIRIFOX versus nab-paclitaxel and gemcitabine (Gem+NabP) in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Subgroup analysis of patients aged 65 years or older in NAPOLI 3.” Presented at ESMO-GI 2024 (Abstract 323P).
