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    DRUG:

    pamrevlumab (FG-3019)

    i
    Other names: FG-3019, FG 3019, FG3019
    Company:
    FibroGen
    Drug class:
    Connective tissue growth factor inhibitor
    Related drugs:
    3ms
    LAPIS: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer (clinicaltrials.gov)
    P3, N=284, Completed, FibroGen | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • fluorouracil topical • pamrevlumab (FG-3019)
    6ms
    Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD (clinicaltrials.gov)
    P3, N=73, Terminated, FibroGen | Trial completion date: May 2024 --> Dec 2023 | Active, not recruiting --> Terminated; Study did not meet its primary endpoint.
    Trial completion date • Trial termination • Combination therapy
    |
    pamrevlumab (FG-3019)
    9ms
    LAPIS: Evaluation of Efficacy and Safety of Neoadjuvant Treatment With Pamrevlumab in Combination With Chemotherapy (Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX) in Participants With Locally Advanced Pancreatic Cancer (clinicaltrials.gov)
    P3, N=284, Active, not recruiting, FibroGen | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • fluorouracil topical • pamrevlumab (FG-3019)
    12ms
    Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P3, N=356, Terminated, FibroGen | Trial completion date: May 2024 --> Aug 2023 | Active, not recruiting --> Terminated; Study did not meet its primary endpoint.
    Trial completion date • Trial termination
    |
    pamrevlumab (FG-3019)
    1year
    FGCL-3019-095: Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov)
    P3, N=372, Terminated, FibroGen | Trial completion date: Apr 2025 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2024 --> Sep 2023; Sponsor Decision
    Trial completion date • Trial termination • Trial primary completion date
    |
    pamrevlumab (FG-3019)
    1year
    MISSION: Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD) (clinicaltrials.gov)
    P2, N=21, Terminated, FibroGen | Active, not recruiting --> Terminated; Sponsor Decision
    Trial termination
    |
    pamrevlumab (FG-3019)
    over1year
    Design and methodology of LAPIS, an ongoing, phase III trial of neoadjuvant pamrevlumab (pam) with chemotherapy (CT) in patients (pts) with unresectable, locally advanced pancreatic cancer (LAPC) (AACR 2023)
    Pts were randomized 1:1 to pam+investigator’s choice CT (gemcitabine 1,000 mg/m2+nab-paclitaxel 125 mg/m2; or either FOLFIRINOX [5-fluoruracil 400 mg/m2+folinic acid/leucovorin 400 mg/m2; 5-fluoruracil 2,400 mg/m2; irinotecan 180 mg/m2; oxaliplatin 85 mg/m2; or mFOLFIRINOX [folinic acid/leucovorin 400 mg/m2; 5-fluoruracil 2,400 mg/m2; irinotecan 180 mg/m2; oxaliplatin 85 mg/m2]), or CT+PBO, then stratified by unreconstructable disease (yes/no) and geographic region...LAPIS enrollment is complete (N=284). Study completion is estimated for early 2024.
    Clinical • P3 data • Metastases
    |
    CTGF (Connective tissue growth factor)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • pamrevlumab (FG-3019)
    almost3years
    Molecular pathways and role of epigenetics in the idiopathic pulmonary fibrosis. (PubMed, Life Sci)
    Drug like nintedanib acts through vascular endothelial growth factor receptors (VEGFR), while drug pirfenidone acts through transforming growth factor (TGF), which is useful in IPF. Gefitinib, a tyrosine kinase inhibitor of EGFR, is useful as an anti-fibrosis agent in preclinical models. Newer drugs such as Celgene-CC90001 and FibroGen-FG-3019 are currently under investigations acts through the modulating epigenetic mechanisms...This study provides an elementary analysis of multiple regulators of epigenetics and their roles associated with the pathology of IPF. Further, this review also includes epigenetic drugs under development in preclinical and clinical stages.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • TERT (Telomerase Reverse Transcriptase)
    |
    gefitinib • nintedanib • pamrevlumab (FG-3019) • BMS-986360
    3years
    [VIRTUAL] BLOCKING CTGF ALLEVIATES PERITONEAL METASTASIS OF DIFFUSE-TYPE GASTRIC CANCER BY DISRUPTING THE INTERPLAY OF CANCER CELLS AND CANCER-ASSOCIATED FIBROBLASTS (UEGW 2021)
    For the drug efficacies evaluation, the peritoneal tumor nodule formation model will be used to investigate the Pamrevlumab/Verteporfin co-administration effect. In diffuse-type GC, PIEZO1 senses the collagen stiffness and transduces the force signal into YAP1 signaling. As the prominent downstream of YAP1, CTGF is transcriptionally activated to strengthen the CAF-collagen microenvironment. Based on animal studies, novel therapeutic strategy, co-targeting YAP1, and CTGF exhibit significant effects to control the diffuse type GC peritoneal metastasis.
    Late-breaking abstract
    |
    YAP1 (Yes associated protein 1) • CDK6 (Cyclin-dependent kinase 6) • CRY1, Cryptochrome Circadian Regulator 1, • MMP9 (Matrix metallopeptidase 9) • LATS1 (Large Tumor Suppressor Kinase 1) • CTGF (Connective tissue growth factor)
    |
    YAP1 overexpression
    |
    Visudyne (verteporfin) • pamrevlumab (FG-3019)
    almost4years
    A Phase 1/2 Trial of Gemcitabine Plus Nab-paclitaxel With or Without FG-3019 as Neoadjuvant Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=37, Active, not recruiting, FibroGen | Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • albumin-bound paclitaxel • pamrevlumab (FG-3019)
    almost5years
    Prognostic utility of inflammation biomarkers in a PDAC trial involving the human anti-CTGF antibody pamrevlumab. (ASCO-GI 2020)
    The influence of inflammation on patient outcomes was examined in a dose-ranging trial of the anti-CTGF antibody pamrevlumab in combination with a fixed regimen of gemcitabine and erlotinib in locally advanced or metastatic PDAC patients (NCT01181245; Picozzi et al. In multivariate Cox models, assessment of pre-treatment CRP levels improved ability to detect significant differences in PDAC patient survival outcomes associated with pamrevlumab treatment. Our results emphasize the utility of accounting for pre-treatment CRP levels as an independent prognostic factor in PDAC treatment effect models. Research Funding: FibroGen
    CRP (C-reactive protein)
    |
    erlotinib • gemcitabine • pamrevlumab (FG-3019)