LG Chem Subsidiary Aveo Enters Phase 3 Clinical Trial for Head and Neck Cancer Treatment

New Drug Candidate Phyclatuzumab Registers Testers in the US

LG Chem is entering Phase 3 clinical trials for 'Piklatuzumab,' a new drug candidate for HPV-negative head and neck cancer that it is developing.

Researchers at LG Chem Life Sciences Division are conducting new drug research activities. [Photo by LG Chem]

On the 17th, LG Chem announced that its U.S. subsidiary, cancer drug developer Aveo Pharmaceuticals, has enrolled the first patient in the U.S. Phase 3 clinical trial 'PIERCE-HN' for Piklatuzumab. Aveo was acquired by LG Chem last year for $571 million (approximately 767.1 billion KRW).

Piklatuzumab is a follow-up anticancer agent to Aveo’s commercialized kidney cancer treatment 'Fotivda.' It is a monoclonal antibody-based targeted anticancer drug that inhibits the action of hepatocyte growth factor (HGF), which promotes tumor growth. In this Phase 3 trial, the efficacy and safety of the combination therapy of Piklatuzumab and Erbitux (generic name cetuximab), a targeted anticancer drug currently used for head and neck cancer treatment, will be evaluated against Erbitux monotherapy as the control group.

To this end, 410 patients with HPV-negative head and neck cancer who have previously received platinum-based chemotherapy and immune checkpoint inhibitors either sequentially as monotherapy or in combination, and who have recurrent or metastatic disease with progression or drug resistance, will be recruited. The primary efficacy endpoint will be overall survival (OS), defined as the time from the start of treatment to death.

The Piklatuzumab and Erbitux combination therapy is currently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA) based on Phase 2 clinical results. The Fast Track program is a rapid review system designed to expedite the development of new drugs that address unmet medical needs.

LG Chem projects that the U.S. head and neck cancer treatment market will grow to $2.7 billion (approximately 3.6 trillion KRW) by 2028, the target year for the global launch of Piklatuzumab. Among these, HPV-negative head and neck cancer, caused by genetic factors or lifestyle habits such as smoking and drinking rather than viral infections like HPV, is estimated to account for 70% of all patients.

Jiwung Son, Head of LG Chem’s Life Sciences Division, said, “Through this clinical trial, we aim to explore innovative treatment solutions for head and neck cancer,” adding, “We will continue to generate results in the new drug field through global new drug development and successful commercialization.” Julie Bauman, Director of the Cancer Center at George Washington University Hospital, also stated, “Despite the advent of the latest immuno-oncology therapies, survival after treatment for patients with advanced head and neck cancer rarely exceeds one year,” and added, “Based on the urgency and potential of this drug combination, we will proceed with this clinical trial.”