LG Chem said Wednesday that its subsidiary AVEO Pharmaceuticals, a U.S. anti-cancer drug developer, has enrolled its first patient in the U.S. phase 3 clinical trial of ficlatuzumab, a new drug for human papillomavirus (HPV) negative head and neck cancer.

AVEO Pharmaceuticals is accelerating the development of its next anti-cancer drug to succeed Fotivda, a kidney cancer drug, after becoming a subsidiary of LG Chem in 2022.

Ficlatuzumab is a monoclonal antibody-based targeted cancer drug that inhibits the action of hepatocyte growth factor (HGF), a tumor growth factor.

In this phase 3 clinical trial, LG Chem will evaluate the efficacy and safety of the combination of ficlatuzumab and Erbitux (cetuximab) against the monotherapy of Erbitux.

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, looking at overall survival (OS), which is the time from treatment start to death.

Based on the phase 2 results of the ficlatuzumab and Erbitux combination, the FDA has designated the combination as a fast-track drug. The fast-track program is one of the expedited review systems operated by the FDA to accelerate the development of new drugs that can meet unmet medical needs.

LG Chem plans to launch the ficlatuzumab in the U.S. and other global markets in 2028. The U.S. market for head and neck cancer drugs is expected to expand from $1.6 billion in 2023 to $2.7 billion in 2028, according to market analysis firm Evaluat.

HPV-negative head and neck cancers, which are caused by genetic factors and lifestyle habits, such as smoking and drinking, rather than viral infections, are analyzed to account for 70 percent of all head and neck cancer patients.

"Through this trial, we will explore innovative therapeutic solutions for the treatment of head and neck cancer," said Son Jee-woong, President of Life Sciences Company at LG Chem. "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 immunotherapies, patients with advanced head and neck cancer rarely survive more than one year after treatment," said Julie E. Bauman, Director of the George Washington University Cancer Center. "This urgency and the potential of the two drug combinations will drive this trial."