P3, N=356, Terminated, FibroGen | Trial completion date: May 2024 --> Aug 2023 | Active, not recruiting --> Terminated; Study did not meet its primary endpoint.

5 months ago

Trial completion date • Trial termination

pamrevlumab (FG-3019)

7ms

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

7 months ago

Trial completion date • Trial termination • Trial primary completion date

pamrevlumab (FG-3019)

8ms

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

8 months ago

Trial termination

pamrevlumab (FG-3019)

1year

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.

1 year ago

Clinical • P3 data • Metastases

CTGF (Connective tissue growth factor)

gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • oxaliplatin • irinotecan • leucovorin calcium • pamrevlumab (FG-3019)

2years

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.

2 years ago

Review • Journal

EGFR (Epidermal growth factor receptor) • TERT (Telomerase Reverse Transcriptase)

gefitinib • nintedanib • pamrevlumab (FG-3019) • BMS-986360

over2years

[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.

over 2 years ago

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)

over3years

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

over 3 years ago

Clinical • Trial completion date • Trial primary completion date

CA 19-9 (Cancer antigen 19-9)

gemcitabine • albumin-bound paclitaxel • pamrevlumab (FG-3019)

over4years

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

over 4 years ago

CRP (C-reactive protein)

erlotinib • gemcitabine • pamrevlumab (FG-3019)