LG Chem to start phase 3 for head, neck cancer drug in US
Ji-Hyun Lee
Jan 17, 2024 (Gmt+09:00)
South Korea’s LG Chem Ltd. announced on Wednesday that its US-based subsidiary Aveo Pharmaceuticals will start Phase 3 clinical trials for its head and neck cancer drug candidate ficlatuzumab.
Ficlatuzumab is a monoclonal antibody-based targeted anticancer agent that inhibits the action of hepatocyte growth factor (HGF), which promotes tumor growth.
In this Phase 3 clinical trial, LG Chem plans to evaluate the efficacy and safety of the targeted anticancer drug Erbitux (cetuximab) as a monotherapy for head and neck cancer treatment, comparing it to the combination therapy of ficlatuzumab and Erbitux.
The trial aims to recruit 410 HPV-negative cervical cancer patients who have previously undergone platinum-based chemotherapy and immunotherapy as monotherapy or in combination.
The study will assess various endpoints, including overall survival (OS) from the start of treatment until death.
The US Food and Drug Administration (FDA) has previously designated the combination of ficlatuzumab and Erbitux as a fast-track drug based on the results of Phase 2 clinical trials. The fast-track program is one of the expedited review procedures run by the FDA to facilitate the development of new drugs that meet unmet medical needs.
LG Chem has a goal to globally launch ficlatuzumab by 2028. According to market analysis firm Evaluate Pharma, the US market for head and neck cancer treatments is expected to expand from $1.6 billion in 2023 to $2.7 billion by 2028.