AVEO Oncology and Biodesix, Inc. announced 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). The results were presented during a poster session at the 2020 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium. 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.