LG Chem said it has finalized the optimal dosing level for its investigational anticancer drug ficlatuzumab in an ongoing global Phase 3 clinical trial.
On February 20, the company announced that its U.S. subsidiary, AVEO Pharmaceuticals, will proceed with the highest tested dose of 20 mg/kg in the Phase 3 study, following a recommendation from an Independent Data Monitoring Committee (IDMC).
The committee reviewed interim data in a blinded manner and recommended continuing the FIERCE-HN trial with the 20 mg/kg dose, selecting it over another dosage level under evaluation.
FIERCE-HN is a comparative Phase 3 study targeting patients with HPV-negative head and neck squamous cell carcinoma who did not respond to platinum-based chemotherapy and immune checkpoint inhibitors, administered either alone or in combination. The trial evaluates the efficacy and safety of ficlatuzumab in combination with cetuximab compared with placebo plus cetuximab.
Researchers plan to enroll between 410 and 500 patients to assess key endpoints, including overall survival. Patient recruitment is currently progressing across multiple regions, including South Korea, the United States and Europe.
Ficlatuzumab is a monoclonal antibody-based targeted therapy designed to inhibit hepatocyte growth factor (HGF), which plays a role in tumor growth and metastasis.
Julie E. Bauman, director of the George Washington University Cancer Center and the trial’s principal investigator, said the dose selection marks an important step in evaluating the potential clinical benefit of the ficlatuzumab combination regimen. She added that with the optimal dose confirmed, the study is expected to proceed with greater momentum.
Son Ji-woong, head of LG Chem’s Life Sciences division, said the company remains focused on improving treatment options for cancer patients through innovative drug development. He noted that LG Chem aims to further clarify the clinical value of ficlatuzumab based on the latest milestone in the trial.
