• Phase III NAPOLI 3 trial is the largest and has the longest follow-up for an interventional study in metastatic pancreatic adenocarcinoma
• Post-hoc analysis of NAPOLI 3 study determined characteristics associated with long-term survival, with median overall survival of 19.5 months amongst long-term survivors receiving irinotecan liposome plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line therapy
• Dose reductions and/or treatment delays for the management of adverse events enabled patients to stay on treatment longer and achieve high cumulative doses of liposomal irinotecan and oxaliplatin

Late-breaking data from the Phase III NAPOLI 3 study were presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. These results found a median overall survival (mOS) of 19.5 months among long-term survivors (n=15) with metastatic pancreatic adenocarcinoma (mPDAC) treated with the irinotecan liposome injection plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line treatment (n=120), with younger age at diagnosis, and certain tumour and metastasis locations associated with long-term survivorship.

Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed annually in the U.S. and nearly 500,000 people globally.3,4 It is often detected after the disease has spread to other parts of the body (metastatic or stage IV)5 and fewer than 20% of people diagnosed with metastatic pancreatic adenocarcinoma (mPDAC) survive longer than one year.

Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.

“When people are diagnosed with metastatic pancreatic adenocarcinoma, the most important question remains: how long will they have with their loved ones,” said Dr. Vincent Chung, Medical Oncologist, City of Hope. “Findings from the NAPOLI 3 post-hoc analysis provide important context on long-term overall survival with the irinotecan liposome (NALIRIFOX) treatment regimen.”

The analysis included patients who survived for 18 months or longer (N=15), with findings showing long term survivors living with mPDAC had a mOS of 19.5 months (interquartile range [IQR]: 18.8–22.6).

Clinical and pathological factors of long-term survivors included younger than average age at time of diagnosis (median age 61.0 (IQR: 49.0–70.5) as well as tumour location.

Fewer patients had tumours in the head or tail of the pancreas (53.3% had the main pancreatic tumour located in the body of the pancreas), a substantial proportion had liver metastasis (66.7%) and ≥3 metastatic sites (53.3%).

Additionally, findings indicate dose reduction and treatment delays resulted in prolonged exposure and higher cumulative doses of the irinotecan liposome (NALIRIFOX) regimen.

Liver metastasis and ≥3 metastatic sites, dose modifications and an otherwise good clinical profile enabled people to achieve a long mOS.

Consideration should be taken when interpreting these results as a post-hoc analysis with a small sample size.

Source: Ipsen