In a bid to accelerate the development of anti-cancer drugs, South Korean chemical company LG Chem announced on Wednesday that its subsidiary AVEO Pharmaceuticals has commenced the U.S. phase 3 clinical trial for Ficlatuzumab – a novel drug designed for human papillomavirus (HPV) negative head and neck cancer.
This marks a crucial step forward in the race to provide effective treatments for a challenging form of cancer. Data from the World Cancer Research Fund International shows that over 18 million cases of cancer were diagnosed in 2020 globally.
According to the firm, the trial will evaluate the efficacy and safety of the combination of 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.
Julie E. Bauman, Director of the George Washington University Cancer Center, said: “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. “This urgency and the potential of the two drug combinations will drive this trial.”
Ficlatuzumab is a monoclonal antibody-based targeted cancer drug that inhibits the action of hepatocyte growth factor (HGF), a tumor growth factor. Based on the phase 2 results of the 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.
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. LG Chem plans to launch in the U.S. and other global markets in 2028 if approved by the U.S. FDA. 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.”
