South Korean conglomerate LG Chem Ltd. has made a pivotal announcement regarding its US subsidiary, Aveo Pharmaceuticals. The company is set to initiate Phase 3 clinical trials for its innovative head and neck cancer drug candidate, ficlatuzumab. This advanced stage of testing marks a crucial step in the drug’s development process.
Ficlatuzumab is a monoclonal antibody-based targeted anticancer agent, primarily focusing on inhibiting the action of hepatocyte growth factor (HGF), a known promoter of tumor growth. This targeted approach is pivotal in combatting specific types of cancer effectively.
In the upcoming Phase 3 trials, LG Chem will evaluate the efficacy and safety of the drug candidate in a comparative study. This study will assess the performance of Erbitux (cetuximab) as a standalone therapy for head and neck cancer treatment against a combination therapy involving both ficlatuzumab and Erbitux.
The trial is ambitious, planning to recruit 410 patients diagnosed with HPV-negative cervical cancer. These patients will have previously undergone treatments involving platinum-based chemotherapy and immunotherapy, either as monotherapy or in combination. The study’s primary focus will be on measuring overall survival rates from the start of the treatment until death.
Significantly, the combination of ficlatuzumab and Erbitux has already garnered attention from the US Food and Drug Administration (FDA), earning a fast-track designation. This status is granted to expedite the review process for drugs that show potential in fulfilling unmet medical needs.
With a strategic aim to launch ficlatuzumab globally by 2028, LG Chem is positioning itself as a key player in the cancer treatment market. The market for head and neck cancer treatments in the US alone is projected to grow significantly, from $1.6 billion in 2023 to an estimated $2.7 billion by 2028, according to Evaluate Pharma. LG Chem’s foray into this sector not only represents a significant business opportunity but also holds the promise of advancing cancer treatment and improving patient outcomes worldwide.
