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    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
    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 primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
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    EWSR1 (EWS RNA Binding Protein 1) • FLI1 (Fli-1 Proto-Oncogene ETS Transcription Factor)
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    temozolomide • Talzenna (talazoparib) • Onivyde (nanoliposomal irinotecan)
    4d
    SGT-53 in Children With Recurrent or Progressive CNS Malignancies (clinicaltrials.gov)
    P1, N=0, Withdrawn, SynerGene Therapeutics, Inc. | Not yet recruiting --> Withdrawn
    Trial withdrawal
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    Avastin (bevacizumab) • temozolomide • irinotecan • Onivyde (nanoliposomal irinotecan) • SGT-53
    6d
    Perioperative NALIRIFOX in patients with resectable pancreatic ductal adenocarcinoma: updated analysis of survival and circulating and genetic biomarkers from the phase II nITRO trial. (PubMed, ESMO Open)
    Long-term results from the nITRO trial confirm the activity of perioperative NALIRIFOX in resectable PDAC. Inflammatory, genomic, and pharmacogenomic biomarkers strongly influenced treatment response, surgical eligibility, survival, and toxicity. Biomarker integration could enable more precise patient stratification and guide personalized perioperative strategies in PDAC.
    P2 data • Journal
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    TNFA (Tumor Necrosis Factor-Alpha) • DPYD (Dihydropyrimidine Dehydrogenase)
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    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    8d
    Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas (clinicaltrials.gov)
    P2, N=41, Completed, Institut de Recherches Internationales Servier | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Sep 2025
    Trial completion • Trial completion date
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    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
    9d
    Impact of UGT1A1*28 polymorphism in patients with metastatic pancreatic ductal adenocarcinoma treated with NALIRIFOX in the NAPOLI 3 trial. (PubMed, Future Oncol)
    To evaluate the effect of UGT1A1*28 homozygosity on the safety profile of NALIRIFOX (liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) in NAPOLI 3 (NCT04083235). This pre-specified exploratory analysis evaluated safety outcomes by UGT1A1*28 status in patients with mPDAC receiving NALIRIFOX or gemcitabine plus nab-paclitaxel in NAPOLI 3...These findings support the use of full NALIRIFOX dosing irrespective of UGT1A1*28 status. www.clinicaltrials.gov identifier is NCT04083235; EudraCT 2018-003585-14.
    Journal
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    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
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    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    12d
    Pancreatic metastases are suppressed by photodynamic therapy and irinotecan through macrophage reprogramming in immunodeficient mice. (PubMed, Neoplasia)
    Given the lack of pronounced polarization effects with either monotherapy alone, these findings suggest that PDT, when combined with nal-IRI, induces antitumor and antimetastatic responses by remodeling innate immunity, even in the absence of adaptive T-cell activity. It also supports macrophage polarization as a key mechanism underlying PDT-nal-IRI combination therapeutic increase both in local and distant tumor burden.
    Preclinical • Journal
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    GZMB (Granzyme B)
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    Onivyde (nanoliposomal irinotecan)
    14d
    Comparison of Nanoliposomal Irinotecan Plus Fluorouracil/Leucovorin and S-1, Irinotecan, and Oxaliplatin as Second-Line Chemotherapy After Gemcitabine Plus Nab-Paclitaxel for Unresectable Pancreatic Cancer. (PubMed, J Hepatobiliary Pancreat Sci)
    S-IROX may be an effective and safe second-line option after GnP, particularly for locally advanced PC.
    Journal
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    CA 19-9 (Cancer antigen 19-9)
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    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Teysuno (gimeracil/oteracil/tegafur) • Onivyde (nanoliposomal irinotecan)
    14d
    Predictors of prolonged progression-free survival in patients with unresectable or recurrent pancreatic cancer treated with nanoliposomal irinotecan with fluorouracil and folinic acid (NAPOLEON-2 study). (PubMed, Ther Adv Med Oncol)
    The duration of previous chemotherapy, treatment line, and the CAR are useful predictors of PFS in patients with urPC receiving NFF. The proposed nomogram and risk stratification system may facilitate individualized treatment planning and support clinical decision-making.
    Journal
    |
    CRP (C-reactive protein)
    |
    5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    18d
    Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=52, Recruiting, Medical University of South Carolina | Initiation date: Nov 2025 --> Apr 2026
    Trial initiation date
    |
    cisplatin • gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    20d
    ClinicaApplication of NALIRIFOX-Based Total Neoadjuvant Therapy in Patients with Locally Advanced Pancreatic Cancer (ChiCTR2600119985)
    P4, N=36, West China Hospital of Sichuan University; West China Hospital of Sichuan University
    New P4 trial
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)
    20d
    A Phase II, Multicenter, Open-Label, Single-Arm Study of Durvalumab in Combination With Gemcitabine and Liposomal Irinotecan (nal-IRI) as First-Line Therapy in Patients With Advanced Biliary Tract Cancer (ChiCTR2600119377)
    P2, N=36, Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    New P2 trial
    |
    CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Onivyde (nanoliposomal irinotecan)
    28d
    PHOLIPANC: Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P=N/A, N=40, Recruiting, The University of Texas Health Science Center at San Antonio | Not yet recruiting --> Recruiting
    Enrollment open
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan)