1520P - Real-world assessment of NALIRIFOX for advanced pancreatic ductal adenocarcinoma: An exploratory analysis

Background

The NAPOLI 3 trial reported a survival benefit with the combination therapy nanoliposomal Irinotecan, 5-Fluorouracil, Leucovorin and Oxaliplatin (NALIRIFOX) versus nabPaclitaxel and Gemcitabine in first line therapy for metastatic pancreatic ductal Adenocarcinoma (mPDAC). In this study we aim to analyze the efficacy and feasibility of this promising new first line regime in an early real-world setting.

Methods

The analyzed population included patients with unresectable or metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX at 3 Austrian cancer centers. The primary endpoint of the study was overall survival (OS), while secondary endpoints included progression free survival (PFS), overall response rate (ORR), and safety. All patient data including molecular profiles were obtained by individual chart review.

Results

From February 2023 to April 2024, 40 patients were enrolled. After a median follow up of 7.9 months (95% CI 6.44-10.36), median PFS was 5.3 months (95% CI 3.45-6.71), and median OS was 12.7 months (95% CI 8.94-NR). The investigator assessed confirmed ORR was 63% and the disease control rate was 78%. Any grade adverse events (AEs) occurred in 40 patients (100%). Grade 3-4 AEs occurred in 17 patients (42.50%). The most common side effects were hypokalemia (53.13%) and diarrhea (52.5%). Among hypokalemia cases, 82% experienced severe (G3/G4) adverse events, while for diarrhea, the percentage of severe AEs was 19%. In 9 patients (22.50%) treatment-emergent adverse events leading to discontinuation. No treatment-related treatment-emergent adverse events leading to death were detected. KRAS was present in 87.5%.

Conclusions

To the best of our knowledge this is the first real-world analysis of NALIRIFOX in pancreatic cancer. Efficacy results confirm the phase NAPOLI 3 trial while holding promising safety.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

A. Reichinger.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.