LG Chem announced on Jan. 17 that U.S. cancer drug developer Aveo Oncology (Aveo) has enrolled its first patient in the U.S. Phase III FIERCE-HN trial of ficlatuzumab for head and neck cancer.
Aveo, a subsidiary of LG Chem, is accelerating development of its next cancer drug to follow up on its kidney cancer drug FOTIVDA.
Ficlatuzumab is a monoclonal antibody-based targeted cancer drug that works by inhibiting the action of tumor-growing hepatocyte growth factor. LG Chem plans to evaluate the efficacy and safety of ficlatuzumab and Erbitux combination therapy in a Phase III clinical trial against Erbitux monotherapy, a targeted anti-cancer drug used to treat head and neck cancer.
The study will recruit 410 patients with HPV-negative head and neck cancer who have previously received platinum-based chemotherapy and an immune checkpoint inhibitor, either sequentially or in combination as monotherapy, and will look at cancer worsening, recurrent and metastatic disease that has become drug resistant, and "overall survival," which is the time from the start of treatment to death.
Based on the Phase 2 results of the ficlatuzumab and Erbitux combination, the U.S. FDA has designated the combination as a fast-track drug. Fast Track is one of the expedited review systems operated by the U.S. FDA to accelerate the development of new drugs that can meet unmet medical needs.
LG Chem plans to launch the product in the U.S. and other global markets in 2028. According to market analysis firm EvaluatePharma, the U.S. market for head and neck cancer drugs is expected to expand from 2 trillion won ($1.6 billion) in 2023 to 3.5 trillion won ($2.7 billion) in 2028.
HPV-negative head and neck cancers, which are caused by genetic factors and lifestyle habits such as smoking and drinking, rather than viral infections, account for 70 percent of all head and neck cancer cases.
"Through this trial, we will explore innovative treatment solutions for the treatment of head and neck cancer," said Ji-woong Son, Head of LG Chem's Life Science Business. "We will continue to create achievements in the field of new drugs through global drug development and successful commercialization."
"Despite the advent of the latest immuno-oncology therapies, patients with advanced head and neck cancer rarely survive more than one year after treatment," said Julie E. Bauman, MD, director of the George Washington University Cancer Center. "This urgency and the potential of the two drug combinations will drive this trial."
