July 27, 2025
During ASCO-GI 2025, Ipsen released a late-breaking post-hoc analysis of the Phase III NAPOLI‑3 trial comparing NALIRIFOX (Onivyde combined with oxaliplatin, 5‑FU, and leucovorin) to Gem-Nab in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). A subgroup of long-term survivors (approximately 15 patients) experienced a median overall survival(OS) of 19.5 months—remarkably longer than typical expectations in this setting. Researchers identified prognostic indicators including younger age(<60 years), distal tumor location, low CA19‑9 levels, and cumulative dose intensity, suggesting that optimized dose management may improve outcomes. These data bolster Onivyde’s competitive edge against Gem-Nab and FOLFIRINOX, enhancing its profile as a powerful front-line regimen in an area of high unmet need.
Citation: https://www.globenewswire.com/news-release/2025/05/31/3091404/0/en/Late-breaking-analysis-demonstrates-characteristics-associated-with-long-term-overall-survival-with-Onivyde-regimen-in-metastatic-pancreatic-adenocarcinoma.html?utm_source=chatgpt.com
Implication:
This survival milestone reinforces NALIRIFOX’s strength and supports its adoption over conventional regimens. Highlighted predictive factors could guide patient selection and payer policies, making Onivyde a more tailored and potentially preferred first-line mPDAC option.