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Review
. 2025 Feb;85(2):255-262.
doi: 10.1007/s40265-024-02133-1. Epub 2025 Jan 17.

Liposomal Irinotecan: A Review as First-Line Therapy in Metastatic Pancreatic Adenocarcinoma

Michael B Brown  1 , Hannah A Blair  2
Affiliations
Review

Liposomal Irinotecan: A Review as First-Line Therapy in Metastatic Pancreatic Adenocarcinoma

Michael B Brown et al. Drugs. 2025 Feb.

Abstract

Liposomal irinotecan (Onivyde®), also known as liposomal pegylated irinotecan, has been developed with the intent of maximising anti-tumour efficacy and minimising drug-related toxicities compared with conventional formulations of this topoisomerase 1 inhibitor. In combination with fluorouracil, leucovorin and oxaliplatin (NALIRIFOX), liposomal irinotecan is approved in the USA and the EU for first-line therapy of eligible patients with metastatic pancreatic adenocarcinoma. In a phase III clinical trial, NALIRIFOX significantly improved overall survival (OS) and progression free survival (PFS) compared with gemcitabine plus nanoparticle albumin bound paclitaxel (nab-paclitaxel) as first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The safety profile of NALIRIFOX was generally manageable, with diarrhoea, hypokalaemia and neutropenia being the most common grade ≥ 3 treatment-emergent adverse events. Although further analyses will help position the liposomal irinotecan-containing regimen NALIRIFOX in first-line treatment of metastatic pancreatic adenocarcinoma, current evidence indicates that it is a useful addition to treatment options in this patient population.

Plain language summary

Pancreatic adenocarcinoma is an invasive tumour arising from the pancreas. Generally, pancreatic adenocarcinoma is diagnosed in later stages having spread to distant sites (advanced/metastatic disease). Liposomal irinotecan (Onivyde®), also known as liposomal pegylated irinotecan, is a liposomal formulation of the topoisomerase 1 inhibitor irinotecan. Encapsulation in liposomes aims to improve the activity and tolerability of irinotecan by protecting the drug in circulation and improving delivery to tumours. When given to adults with metastatic pancreatic ductal adenocarcinoma (mPDAC) in a clinical trial, a combination of liposomal irinotecan, fluorouracil, leucovorin and oxaliplatin (NALIRIFOX) improved survival outcomes compared with the established first-line treatment combination of gemcitabine plus nanoparticle bound albumin paclitaxel (nab-paclitaxel) and had a generally manageable safety profile. Although further analyses will help position the liposomal irinotecan-containing regimen NALIRIFOX in first-line treatment of metastatic pancreatic adenocarcinoma, current evidence indicates that is a useful addition to treatment options in this patient population.

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Conflict of interest statement

Declarations. Funding: The preparation of this review was not supported by any external funding. Authorship and Conflict of Interest: Michael B. Brown and Hannah A. Blair are salaried employees of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to this article and are responsible for its content. Ethics Approval, Consent to Participate, Consent to Publish, Availability of Data and Material, Code Availability: Not applicable.

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