^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Onivyde (nanoliposomal irinotecan)

    i
    Other names: MM-398, MM 398, MM398, PEP 02, PEP02, nal-IRI, SHP673, SHP-673, BAX-2398, S095013, BAX 2398, BAX2398, PEP-02, S-095013, S 095013, SHP 673
    Company:
    Ipsen, PharmaEngine, Servier
    Drug class:
    Topoisomerase I inhibitor
    Related drugs:
    4d
    Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II) (clinicaltrials.gov)
    P1, N=10, Recruiting, SONIRE Therapeutics Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    albumin-bound paclitaxel • irinotecan • Onivyde (nanoliposomal irinotecan)
    5d
    Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, University of Wisconsin, Madison | Active, not recruiting --> Recruiting | N=25 --> 50 | Trial completion date: Jul 2026 --> Jul 2028 | Trial primary completion date: Jul 2026 --> Jul 2028
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 positive • RAS wild-type • RAS wild-type + HER-2 positive • HER-2 positive + RAS wild-type
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • Onivyde (nanoliposomal irinotecan)
    14d
    Second-line chemotherapy after gemcitabine plus nab-paclitaxel in metastatic pancreatic cancer: comparative outcomes and AI-guided treatment selection. (PubMed, Oncologist)
    FOLFIRINOX appears the most effective option for carefully selected, fit patients eligible for 2L chemotherapy after GnP failure. Interpretable artificial intelligence-derived treatment policies may provide superior net clinical benefit compared to uniform approaches and guide individualized therapy, warranting integration with upcoming targeted strategies such as RAS inhibitors.
    Journal
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    22d
    SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC (clinicaltrials.gov)
    P=N/A, N=49, Recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    New trial
    |
    Tyvyt (sintilimab) • capecitabine • Onivyde (nanoliposomal irinotecan)
    22d
    A Study of Suizenji in Patients With Unresectable Pancreatic Cancer (clinicaltrials.gov)
    P=N/A, N=90, Active, not recruiting, SONIRE Therapeutics Inc. | Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> May 2027 | Trial primary completion date: Sep 2026 --> May 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    albumin-bound paclitaxel • oxaliplatin • irinotecan • Onivyde (nanoliposomal irinotecan)
    1m
    FOLFIRINOX vs. Gemcitabine/Nab-Paclitaxel for Pancreatic Cancer by BRCA2 and TMB Status: A Japanese C-CAT Database Study. (PubMed, Cancer Sci)
    Among patients with BRCA2 PVs treated with GnP, OS was numerically longer with second-line FFX than with nal-IRI/5-FU/leucovorin (HR 0.51; p = 0.119)...In BRCA2 PV tumors, greater tumor shrinkage with first-line FFX did not translate into longer OS, underscoring the importance of sequencing strategies that ensure timely exposure to platinum-based therapy. TMB-high tumors may benefit from timely access to immunotherapy.
    Journal • Tumor mutational burden • BRCA Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden) • BRCA2 (Breast cancer 2, early onset)
    |
    TMB-H
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    1m
    A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (clinicaltrials.gov)
    P3, N=614, Recruiting, Astellas Pharma Global Development, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • setidegrasib (ASP3082) • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    1m
    NEO-Nal- IRI: A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, University of Florida | Trial completion date: Feb 2026 --> Dec 2026
    Trial completion date
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1) • CA 19-9 (Cancer antigen 19-9)
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    2ms
    Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (clinicaltrials.gov)
    P3, N=94, Recruiting, SWOG Cancer Research Network | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NRG1 (Neuregulin 1)
    |
    BRAF V600E • MSI-H/dMMR • PALB2 mutation • KRAS wild-type • BRAF wild-type • RAS wild-type • ROS1 fusion • NRG1 fusion
    |
    gemcitabine • Vectibix (panitumumab) • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • fluorouracil topical
    2ms
    A Study to Confirm the Safety of ASP3082, and if it Delays Tumor Growth in People With Pancreatic Cancer, When Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies (clinicaltrials.gov)
    P3, N=614, Not yet recruiting, Astellas Pharma Global Development, Inc.
    New P3 trial
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12D • KRAS G12
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • setidegrasib (ASP3082) • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    2ms
    CLARITY-PanTumor01: AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 (clinicaltrials.gov)
    P2, N=224, Recruiting, AstraZeneca | Trial completion date: Dec 2026 --> Sep 2027 | Trial primary completion date: Dec 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • Pan tumor
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 positive
    |
    gemcitabine • 5-fluorouracil • leucovorin calcium • sonesitatug vedotin (AZD0901) • Onivyde (nanoliposomal irinotecan)
    2ms
    ONITT: Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma (clinicaltrials.gov)
    P1/2, N=90, Recruiting, St. Jude Children's Research Hospital | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)
    |
    temozolomide • Talzenna (talazoparib) • Onivyde (nanoliposomal irinotecan)