LG Chem Initiates Phase 3 Clinical Trial for Head and Neck Cancer Drug

LG Chem Initiates Phase 3 Clinical Trial for Head and Neck Cancer Drug

■ Following the acquisition last year, AVEO Oncology has accelerated the development of its HPV-negative head and neck cancer drug candidate Ficlatuzumab, with the enrollment of a phase 3 clinical trial.
- A targeted monoclonal antibody inhibiting the action of Hepatocyte Growth Factor (HGF), known to stimulate tumor growth.
- Planned to be assessed as a second-line treatment for patients resistant to cancer immunotherapy.

■ Anticipated to launch in 2028 if approved, the U.S. market is expected to be valued at KRW 3.5 trillion.

LG Chem commenced a crucial Phase 3 clinical trial aimed at expanding potential treatment options for patients with HPV (Human Papillomavirus) negative head and neck cancer.

LG Chem announced on 17th that AVEO Pharmaceuticals(“AVEO”), which is a LG Chem’s biopharmaceutical company focused on oncology, has officially initiated the Ficlatuzumab in combination with ERBITUX® (cetuximab) Phase 3 Clinical Evaluation (named FIERCE-HN) for the head and neck cancer investigational drug Ficlatuzumab, enrolling the first participant in the study. Following its acquisition by LG Chem, AVEO has been seeking to accelerate the development of new cancer treatments, following its renal cell carcinoma drug FOTIVDA®.

Ficlatuzumab is AVEO’s investigational antibody that targets HGF(hepatocyte growth factor). In this Phase 3 trial, LG Chem plans to evaluate the efficacy and safety of the combined therapy of Ficlatuzumab and ERBITUX®, which is currently used in head and neck cancer treatment, against a control group receiving only ERBITUX®.

The trial aims to recruit 410 patients with HPV-negative recurrent or metastatic head and neck cancer who were previously treated with platinum-based chemotherapy and immune checkpoint inhibitors, either as monotherapies or in combination. The study will observe the overall survival (OS) from the start of the treatment until death.

Following results from the Phase 2 clinical trial of Ficlatuzumab in combination with ERBITUX® the U.S. FDA designated the combination as a Fast Track drug in 2021, which is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, potentially enabling drugs to reach patients earlier.

If approved by the U.S. FDA, LG Chem plans to launch the product in the global market, including the United States, by 2028. According to market analysis by Evaluate Pharma, the U.S. market for head and neck cancer treatments is projected to grow from KRW 2 trillion (USD 1.6 billion) in 2023 to KRW 3.5 trillion (USD 2.7 billion) by 2028. HPV-negative head and neck cancer, often caused by genetic factors and lifestyle habits (such as smoking and drinking), accounts for approximately 70% of all head and neck cancer cases.

Jeewoong Son, Head of the Life Sciences Company at LG Chem, stated, “We will find innovative solutions for head and neck cancer treatment. We will continue to create results in the field of new drug development and successful commercialization globally.”

Julie E. Bauman, Director of the George Washington Cancer Center, commented, “Despite the advent of the latest immunotherapy for advanced head and neck cancer, few patients with advanced disease survive longer than a year after treatment. We therefore approach the FIERCE-HN trial with a mix of urgency and optimism, as the combination of Ficlatuzumab and ERBITUX® has the potential to expand the range of viable therapeutic options for this underserved population.”

[Reference] Phase 2 Clinical Results >

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