Liposomal irinotecan
Irinotecan wrapped in a fat bubble so it circulates longer. It is approved for pancreatic cancer, and in bile duct and gallbladder cancer one Korean trial found it helped as second-line treatment while a German trial did not.
Overview
Liposomal irinotecan is a nanoliposomal formulation of irinotecan that prolongs circulation of the active metabolite SN-38 and increases tumour exposure. It is approved for metastatic pancreatic adenocarcinoma after gemcitabine-based therapy (NAPOLI-1; United States 2015, European Union 2016) and, with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX), as first-line treatment of metastatic pancreatic adenocarcinoma (NAPOLI 3; United States 2024). In biliary tract cancer it has no licence. The Korean NIFTY phase 2b trial randomised 174 patients who had progressed on gemcitabine and cisplatin to fluorouracil and leucovorin with or without liposomal irinotecan: blinded central review progression-free survival was 7.1 versus 1.4 months (hazard ratio 0.56) at the first analysis and 4.2 versus 1.7 months (hazard ratio 0.61) when the scans were re-read with extended follow-up, with grade 3 to 4 neutropenia in 24 percent versus 1 percent. The German NALIRICC trial (100 patients) found no benefit, and the earlier German NIFE trial compared it non-comparatively with gemcitabine and cisplatin in first line. NCCN lists it as an option after gemcitabine and cisplatin; in the UK it is not commissioned for biliary cancer, where FOLFOX (ABC-06) is the second-line standard. UGT1A1 poor metabolisers need dose reduction.
- Chromosomes at spindle
- Drug blocks division / damages DNA
Liposomal delivery of irinotecan; SN-38 traps topoisomerase I and DNA in cleavage complexes.
1.Liposomal irinotecan slips into a pocket on its target.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas · Lines of therapy.
- Route
- Intravenous
- Schedule
- 70 mg/m² over 90 minutes every 2 weeks with leucovorin 400 mg/m² and fluorouracil 2,400 mg/m² over 46 hours (NIFTY schedule)
- Dose modifications
- Reduced dose for UGT1A1*28 homozygotes
- Monitoring
- Neutrophil count, diarrhoea
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Metastatic pancreatic adenocarcinoma after gemcitabine-based therapy, with fluorouracil and leucovorin (NAPOLI-1) · FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Onivyde |
| EU | 2016 | Metastatic pancreatic adenocarcinoma after gemcitabine, with fluorouracil and leucovorin · EMA EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal |
| US | 2024 | First-line metastatic pancreatic adenocarcinoma in NALIRIFOX (NAPOLI 3) · FDA label (DailyMed) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia (grade 3-4) NIFTY, liposomal irinotecan arm | - | 24% |
| Fatigue or asthenia (grade 3-4) NIFTY | - | 13% |
Rates read from the source. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topTrials recruiting now
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Landmark trials
Latest papers
topQuery for this drug: (TITLE:"Liposomal irinotecan" OR ABSTRACT:"Liposomal irinotecan" OR TITLE:"Onivyde" OR ABSTRACT:"Onivyde" OR TITLE:"nal-IRI" OR ABSTRACT:"nal-IRI" OR TITLE:"MM-398" OR ABSTRACT:"MM-398" OR TITLE:"PEP02" OR ABSTRACT:"PEP02") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Liposomal irinotecan, not a curated reading list.
Similar pages
not linked directly; found by shared links- Key paperLiposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): a multicentre, open-label, randomised, phase 2b study
Shares NALIRICC (AIO), NIFTY, Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer.
- TreatmentNALIRIFOX (liposomal irinotecan + oxaliplatin + 5-FU/LV)
Shares Ipsen, Topoisomerase-I inhibitors (and ADC payloads), Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma.
- TreatmentLeucovorin (folinic acid)
Shares NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer, NALIRICC (AIO), NIFE (AIO-YMO HEP-0315), Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma.
- Key paperNAPOLI-3: NALIRIFOX versus gemcitabine plus nab-paclitaxel as first treatment for metastatic pancreatic cancer
Shares Servier, Topoisomerase-I inhibitors (and ADC payloads), Cytotoxic chemotherapy, Pancreatic ductal adenocarcinoma.
- TrialABC-06
Shares NIFTY, Biliary tract cancer (cholangiocarcinoma), Gallbladder cancer, Cytotoxic chemotherapy.
- TrialA Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
Shares Ipsen, Pancreatic ductal adenocarcinoma.
- TrialAn Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
- CompanyMerrimack Pharmaceuticals
Shares Ipsen, Pancreatic ductal adenocarcinoma.