LG Chem’s ficlatuzumab phase 3 trial cleared to proceed at 20 mg/kg dose

LG Chem said Friday that AVEO, which oversees its U.S. oncology business, has finalized the maximum dose of 20 mg/kg as the appropriate administration level for ficlatuzumab, currently in a phase 3 clinical trial, and will continue the study.

(Credit: LG Chem)

The decision was made after the Independent Data Monitoring Committee (IDMC), which has the authority to access blinded information independently of the company during the clinical trial phase, recommended continuing the trial based on interim results from the phase 3 study, FIERCE-HN. The IDMC selected the maximum dose of 20 mg/kg from the two tested doses.

The FIERCE-HN study compares ficlatuzumab plus cetuximab with placebo plus cetuximab in patients with HPV (human papillomavirus)-negative head and neck cancer who previously received platinum-based chemotherapy and immune checkpoint inhibitors, either sequentially as monotherapies or in combination.

The trial plans to enroll a minimum of 410 and a maximum of 500 patients to evaluate outcomes including overall survival (OS), defined as the time from treatment initiation to death. Recruitment is currently underway in multiple countries, including Korea, the United States, and Europe, as planned.

Ficlatuzumab is a monoclonal antibody–based targeted anticancer drug that works by inhibiting hepatocyte growth factor (HGF), which is involved in tumor growth and metastasis.

“This is a significant milestone, bringing us one step closer to confirming the potential clinical benefits of the combination therapy based on ficlatuzumab,” said Dr. Julie E. Bauman, director of the Cancer Center at George Washington University and the lead investigator for the trial. “We hope that determining the optimal dose will allow the clinical trial to progress even more rapidly.”

Son Jee-woong, head of the Life Science Business Division at LG Chem, said, “We are dedicated to improving cancer patient care through the development of innovative medicines. Building on this meaningful achievement, we will focus our efforts on establishing the clinical value of ficlatuzumab.”