On January 27, 2020 AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. reported the presentation of results from an investigator-sponsored Phase 1b trial of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC) (Press release, AVEO, JAN 27, 2020, View Source [SID1234553589]). The results were presented during a poster session at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium. A copy of the presentation, titled "Phase 1b Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab in Patients with Advanced Pancreatic Cancer" (abstract 693), is available in the Publications & Presentations section of AVEO’s website.
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The study, which was based on preclinical findings demonstrating a synergistic effect of the combination in a preclinical model of PDAC, was designed to determine the maximum tolerated dose of ficlatuzumab when combined with gemcitabine and nab-paclitaxel. Secondary outcome measures included response rate and progression free survival. A total of 24 patients were enrolled. The average number of 28-day cycles received was 7.5 (range 1-15), with 3 patients remaining on active treatment. The combination was associated with a promising durable response rate relative to expectations for gemcitabine and nab-paclitaxel alone. This included a 29% partial response (PR) rate and 92% rate of disease control (PR + stable disease). Treatment with this regimen was associated with significant hypoalbuminemia and edema, and therefore a follow up safety study is under consideration of ficlatuzumab in combination with an alternate cytotoxic regimen.
"Pancreatic cancer remains among the most challenging diseases to treat, owing to late diagnoses, rapid progression and early mortality," said Kimberly Perez, MD, Dana-Farber Cancer Institute. "By targeting the c-MET pathway, ficlatuzumab inhibits the Prrx1b-HGF signaling associated with pancreatic development, pancreatitis, and carcinogenesis. These Phase 1b results show encouraging responses that support the further study of ficlatuzumab in pancreatic cancer."
"Ficlatuzumab continues to emerge as a promising clinical candidate, with these results adding to a growing body of clinical data in acute myeloid leukemia and head and neck cancer," said Michael Bailey, president and chief executive officer of AVEO. "As we continue to execute on our tivozanib Phase 3 clinical and U.S. registration strategy and move closer to its potential commercialization, we look forward to seeing ficlatuzumab progress in multiple clinical studies, with the goal of determining a pivotal strategy, assuming favorable study outcomes."
"Ficlatuzumab continues to demonstrate the potential for major clinical utility in areas of significant unmet need," said Scott Hutton, Chief Executive Officer of Biodesix. "We look forward to continuing our diagnostic development work alongside AVEO to help realize the full potential of this promising therapeutic candidate."
About Ficlatuzumab
Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (SCCHN), metastatic pancreatic ductal cancer (PDAC), and acute myeloid leukemia (AML).