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MM-398
MM-398 is a liposomal formulation of irinotecan that delivers the topoisomerase I inhibitor directly to tumor cells while reducing systemic toxicity.
MM-398 is a liposomal formulation of irinotecan that delivers the topoisomerase I inhibitor directly to tumor cells while reducing systemic toxicity. Used for Metastatic pancreatic cancer (in combination with 5-fluorouracil and leucovorin), Metastatic colorectal cancer.
At a glance
| Generic name | MM-398 |
|---|---|
| Also known as | GROUP A, GROUPE B, Onivyde, PEP02 |
| Sponsor | Ipsen |
| Drug class | Liposomal topoisomerase I inhibitor |
| Target | Topoisomerase I |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
MM-398 (nal-IRI) encapsulates irinotecan in lipid nanoparticles that preferentially accumulate in tumors through passive targeting. This allows higher drug concentrations at the tumor site while reducing exposure to normal tissues, thereby improving the therapeutic index of irinotecan. The active metabolite SN-38 inhibits topoisomerase I, leading to DNA damage and cancer cell death.
Approved indications
- Metastatic pancreatic cancer (in combination with 5-fluorouracil and leucovorin)
- Metastatic colorectal cancer
Common side effects
- Neutropenia
- Diarrhea
- Fatigue
- Nausea
- Vomiting
- Abdominal pain
Key clinical trials
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (PHASE3)
- Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread (PHASE2)
- Apatinib Combined With Liposomal Irinotecan for Refractory or Metastatic Osteosarcoma (PHASE1, PHASE2)
- Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma (PHASE2)
- SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC (NA)
- A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment (PHASE3)
- Liposomal Irinotecan, Vincristine, Temozolomide, and Anlotinib for R/R Pediatric Solid Tumors (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MM-398 CI brief — competitive landscape report
- MM-398 updates RSS · CI watch RSS
- Ipsen portfolio CI