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NAPOLI-1 gave pancreatic cancer its first licensed second-line treatment: liposomal irinotecan with fluorouracil extended median survival from 4.2 to 6.1 months after gemcitabine had failed, while the liposome alone did nothing. It is approved in the United States and Europe but NICE turned it down in 2017.
NAPOLI-1 randomised 417 patients between January 2012 and September 2013: 117 to nanoliposomal irinotecan 80 mg/m2 with fluorouracil and folinic acid every two weeks (an arm added by amendment), 151 to nanoliposomal irinotecan 120 mg/m2 alone every three weeks and 149 to fluorouracil and folinic acid. Median overall survival was 6.1 months (95 percent confidence interval 4.8 to 8.9) with the combination against 4.2 months (3.3 to 5.3) with fluorouracil and folinic acid (hazard ratio 0.67, 0.49 to 0.92; p 0.012), while monotherapy gave 4.9 months (hazard ratio 0.99). Grade 3 or 4 neutropenia occurred in 27 percent, diarrhoea 13 percent, vomiting 11 percent and fatigue 14 percent of the combination arm. Four UK sites took part (Liverpool, London, Manchester, Sutton). The FDA approved Onivyde with fluorouracil and leucovorin in October 2015 and the European Commission on 14 October 2016 (orphan designation 2011); NICE TA440 (26 April 2017) does not recommend it within its marketing authorisation, a position NG85 restates (1.9.9). The same liposomal irinotecan later formed the NALIRIFOX first-line regimen tested in NAPOLI 3.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
417 enrolled.
95% CI 4.8 to 8.9 · 95% CI 4.2 to 5.6; HR 0.99 versus control · 95% CI 3.3 to 5.3
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Nanoliposomal irinotecan + fluorouracil/folinic acid | 117 | 6.1 months | 0.67 (0.49 to 0.92) | 0.012 | link |
| Nanoliposomal irinotecan alone | 151 | 4.9 months | ||||
| Fluorouracil/folinic acid | 149 | 4.2 months |
Shares NAPOLI 3, Ipsen, Liposomal irinotecan, Fluorouracil (5-FU).
Shares Liposomal irinotecan, Leucovorin (folinic acid), Fluorouracil (5-FU), Topoisomerase-I inhibitors (and ADC payloads).
Shares Liposomal irinotecan, Leucovorin (folinic acid), Fluorouracil (5-FU), Topoisomerase-I inhibitors (and ADC payloads).
Shares NAPOLI 3, Leucovorin (folinic acid), Fluorouracil (5-FU), Topoisomerase-I inhibitors (and ADC payloads).
Shares Liposomal irinotecan, Fluorouracil (5-FU), Topoisomerase-I inhibitors (and ADC payloads), Metastatic pancreatic ductal adenocarcinoma.
Shares RASolute 302, Leucovorin (folinic acid), Fluorouracil (5-FU), Metastatic pancreatic ductal adenocarcinoma.
Shares NAPOLI 3, RASolute 302, Pancreatic cancer drugs in England: NICE appraisals and the Cancer Drugs Fund (September 2026), Ipsen.
Shares Liposomal irinotecan, Fluorouracil (5-FU), Topoisomerase-I inhibitors (and ADC payloads), Metastatic pancreatic ductal adenocarcinoma.