Drugs / Irinotecan Sucrosofate
Irinotecan Sucrosofate
also known as
MM-398 · PEP02 · Nal-IRI · Irinotecan Sucrosofate Liposome Injection · Liposome Irinotecan · liposome-encapsulated irinotecan hydrochloride · Nanoliposomal Irinotecan
Other / unclassified targets TOP1 via inhibition
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT02631733 | May 2017 → Nov 2019 | cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02640365 | Nov 2015 → Dec 2016 | — | GERCOR - Multidisciplinary Oncology Cooperative Group | Completed | No outcome recorded |
| Phase 1 | NCT02013336 | Dec 2013 → Dec 2026 expected | Ewing sarcoma, neuroblastoma, osteosarcoma, rhabdomyosarcoma | South Plains Oncology Consortium | Recruiting | No outcome recorded |
| Phase 1 | NCT01770353 | Nov 2012 → Oct 2018 | hormone receptor-positive breast cancer, metastatic malignant neoplasm in the brain, triple-negative breast carcinoma | Ipsen | Completed | No outcome recorded |
| Phase 1 | NCT00940758 | Jun 2009 → May 2012 | colorectal cancer | PharmaEngine | Completed | No outcome recorded |
| Phase 1 | NCT02884128 | Jan 2006 → Aug 2008 | neoplasm | PharmaEngine | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04753216 | Mar → Aug 2021 | fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT01375816 | May 2011 → Jun 2014 | colorectal cancer | GERCOR - Multidisciplinary Oncology Cooperative Group | Terminated | No outcome recorded |
| Phase 2 | NCT00813163 | Jan 2009 → Dec 2010 | malignant pancreatic neoplasm | PharmaEngine | Completed | Met primary |
| Phase 2 | NCT00813072 | Nov 2007 → Jul 2010 | gastric neoplasm, neoplasm of esophagus | PharmaEngine | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT01494506 | Nov 2011 → Feb 2014 | malignant pancreatic neoplasm | Merrimack Pharmaceuticals | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT02231723 Background | Aug 2014 → Jun 2020 | pancreatic adenocarcinoma | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT06998940 Background | May 2026 → Dec 2029 expected | pancreatic adenocarcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-05-31 | Ipsen | Results Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma ipsen.com ↗
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 Onivyde® plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) regimen as a first-line therapy2 |
| 2024-12-02 | Purple Biotech Ltd. | Results Purple Biotech Reports Positive Final Results from Randomized Phase 2 Study of CM24 in Second Line Pancreatic Cancer purple-biotech.com ↗
Final data demonstrate CM24 in combination with nivolumab and Nal-IRI/5FU/LV chemotherapy clear and consistent improvement across all efficacy endpoints |
| 2024-06-27 | Purple Biotech Ltd. | Results Purple Biotech Reports Additional Positive Interim Results from its Randomized Phase 2 Pancreatic Cancer Study with CM24 Regarding a Potential Predictive Biomarker for Overall Survival Benefit purple-biotech.com ↗
These results suggest that serum MPO may be a predictive biomarker for survival in the CM24+Nivolumab + Nal-IRI/5FU/LV arm. |
| 2024-06-01 | Purple Biotech Ltd. | Results Purple Biotech Announces Positive Late-Breaking Interim Randomized Phase 2 Data at ASCO 2024 Demonstrating CM24 Improved Overall Survival and other Efficacy Endpoints in Pancreatic Cancer purple-biotech.com ↗
These exciting interim data demonstrate the potential of CM24 in combination with nivolumab plus the standard-of-care chemotherapy regimen Nal-IRI/5FU/LV to improve clinical outcomes for advanced metastatic PDAC patients. |
| 2024-04-25 | Purple Biotech Ltd. | Results Purple Biotech's Randomized Phase 2 CM24 Pancreatic Cancer Study Selected as Late-Breaking Abstract Poster Presentation at ASCO 2024 Annual Meeting purple-biotech.com ↗
Interim data suggests reduced risk of progression or death in the CM24/nivolumab plus standard of care Nal-IRI/5FU/LV arm of the study |
| 2024-02-13 | Ipsen | Regulatory Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA ipsen.com ↗
With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the U.S. |
| 2023-06-14 | Ipsen | Regulatory Correction: Ipsen announces U.S. FDA submission acceptance of its supplemental New Drug Application for Onivyde regimen in first-line metastatic pancreatic ductal adenocarcinoma ipsen.com ↗ |
| 2023-01-20 | Ipsen | Results Ipsen presents Phase III NAPOLI 3 trial of Onivyde® regimen demonstrating positive survival results in previously untreated metastatic pancreatic ductal adenocarcinoma at ASCO GI ipsen.com ↗
Investigational Onivyde® (irinotecan liposome injection) in the NALIRIFOX treatment regimen demonstrated statistically significant improvements in overall survival and progression-free survival compared to nab-paclitaxel plus gemcitabine with a manageable safety profile1 |
| 2022-11-09 | Ipsen | Results Onivyde® regimen demonstrated statistically significant improvement in overall survival in previously untreated metastatic pancreatic ductal adenocarcinoma ipsen.com ↗
Trial met its primary endpoint with Onivyde® (irinotecan liposome injection) in the NALIRIFOX treatment regimen showing statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine regimen |
| 2022-08-03 | Ipsen | Results Ipsen announces results from Phase III RESILIENT trial evaluating Onivyde® in second-line monotherapy for small cell lung cancer ipsen.com ↗
The analysis concluded that the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. |
| 2020-11-30 | Ipsen | Regulatory Ipsen receives FDA Fast Track designation for investigational irinotecan liposome injection (ONIVYDE®) as a second-line monotherapy treatment for small cell lung cancer (SCLC) ipsen.com ↗ |
| 2020-06-17 | Ipsen | Regulatory Ipsen receives FDA Fast Track designation for liposomal irinotecan (ONIVYDE®) as a first-line combination treatment for metastatic pancreatic cancer ipsen.com ↗ |
| 2019-09-08 | Ipsen | Results Ipsen and Servier announce initial Phase II/III clinical data evaluating investigational liposomal irinotecan (ONIVYDE®) as a second-line treatment for small cell lung cancer (SCLC) at the IASLC 2019 World Conference on Lung Cancer ipsen.com ↗
Ipsen (Euronext: IPN; ADR: IPSEY) and Servier announced today initial safety and efficacy data from Part 1 of the Phase II/III RESILIENT study of investigational liposomal irinotecan (ONIVYDE®) in patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen. |
| 2019-07-05 | Ipsen | Results Ipsen and Servier announce initial Phase 1/2 clinical data evaluating liposomal irinotecan (ONIVYDE®) as an investigational first-line treatment for metastatic pancreatic cancer at ESMO 21st World Congress on Gastrointestinal Cancer ipsen.com ↗
71.9% (23/32) of study patients in the 50/60 PP achieved disease control at 16 weeks. |
| 2018-06-22 | Takeda | Results Large-Scale European Review Suggests Disparity in Symptom Recognition and Standardized Treatment for Metastatic Adenocarcinoma of the Pancreas takeda.com ↗
These analyses demonstrated that a consistent treatment benefit was observed in patients treated with nal-IRI in combination with 5-FU/LV across the subgroups tested. |
| 2016-10-18 | Takeda | Regulatory Shire Granted EU Marketing Authorization of ONIVYDE®, In Combination With 5-Fluorouracil (5-FU) And Leucovorin (LV), For The Treatment of Metastatic Adenocarcinoma Of The Pancreas in Adult Patients Who Have Progressed Following Gemcitabine-Based Therapy takeda.com ↗
ONIVYDE, in combination with 5- fluorouracil (5-FU) and leucovorin (LV), is the first and only treatment approved for this patient population based on pivotal Phase 3 data (NAPOLI-1) showing increased overall survival i,ii |
| 2016-07-25 | Takeda | Regulatory ONIVYDE® Receives Positive CHMP Opinion for Treatment of Patients with Metastatic Adenocarcinoma of the Pancreas who have Progressed Following Gemcitabine based Therapy takeda.com ↗
We therefore welcome the CHMP positive opinion for ONIVYDE, a regulatory milestone which brings us a step closer to helping patients with this devastating disease. |
| 2014-05-01 | TTY Biopharm | Results 智擎公司宣佈第三期臨床試驗數據顯示MM-398 (PEP02) 加上5-FU/LV合併療法能延長晚期胰臟癌患者的整體存活期 com.tw ↗ |
All press releases naming this drug 18 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Irinotecan Sucrosofate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02631733 ↗ |
| Known as | Irinotecan Sucrosofate Liposome Injection | “MM-398 (Irinotecan Sucrosofate Liposome Injection)” NCT02013336 ↗ |
| Known as | Liposome Irinotecan | “PEP02 (Liposome Irinotecan)” NCT00940758 ↗ |
| Known as | liposome-encapsulated irinotecan hydrochloride | “RATIONALE: Drugs used in chemotherapy, such as liposome-encapsulated irinotecan hydrochloride PEP02, irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in...” NCT01375816 ↗ |
| Known as | MM-398 | “A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal...” PMID 23406728 ↗ Feb 20137“A multinational phase 2 study of nanoliposomal irinotecan sucrosofate (PEP02, MM-398) for patients with gemcitabine-refractory metastatic pancreatic cancer.” PMID 23880820 ↗ Jul 2013 “PEP02 (also known as MM-398, nal-IRI) is a novel nanoparticle formulation of irinotecan encapsulated in liposomes.” PMID 27871319 ↗ Nov 2016 |
| Known as | Nal-IRI | “PEP02 (also known as MM-398, nal-IRI) is a novel nanoparticle formulation of irinotecan encapsulated in liposomes.” PMID 27871319 ↗ Nov 20161“MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels” NCT01770353 ↗ |
| Known as | Nanoliposomal Irinotecan | “MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels” NCT01770353 ↗ |
| Known as | PEP02 | “A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal...” PMID 23406728 ↗ Feb 20135“MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan” NCT02640365 ↗ |
| Action | Inhibit | “Irinotecan liposome may help block the formation of growths that may become cancer.” NCT04753216 ↗1“DNA topoisomerase I inhibitor” CHEMBL5314381 ↗ |
| Modality | Other / unclassified | “MM-398 (also known as PEP02) is nanoliposomal encapsulated irinotecan” NCT02640365 ↗ |
| Route | Intravenous | “Intravenous injection of PEP02 120 mg m(-2) was given every 3 weeks.” PMID 23880820 ↗ Jul 2013 |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL5314381 ↗ |