AVEO - Model Ficlatuzumab - Investigational Drug (anti-HGF IgG1 mAb)
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway.
Ficlatuzumab is currently being evaluated in squam...
Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and metastatic pancreatic ductal cancer (PDAC).
Results from a randomized confirmatory Phase 2 study of ficlatuzumab as a single agent or in combination with cetuximab (ERBITUX®), an EGFR-targeted antibody, in patients who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab (pan-refractory) with metastatic head and neck squamous cell carcinoma (HNSCC) demonstrated that the ficlatuzumab and cetuximab combination arm met the study’s primary endpoint of median PFS, with the 32 evaluable patients in the arm demonstrating a median PFS of 3.6 months. Of note, patients with HPV negative disease, which is associated with poorer outcomes compared to HPV positive disease, who received the combination demonstrated prolonged PFS (4.1 months) and a response rate of 38%, which included 18% CRs. The Company expects to make a go/no-go decision on the initiation of a pivotal Phase 3 study of ficlatuzumab in HPV negative HNSCC following feedback from the U.S. Food and Drug Administration.
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