Recommended dose of ‘pyruvilclatuzumab’ set at 20mg/kg On recommendation of the Independent Data Monitoring Committee (IDMC) Phase 3 trial to confirm overall survival in more than 410 patients including in Korea Placebo-controlled evaluation of combination therapy with cetuximab
LG Chem announced on the 20th that it has selected 20mg/kg, the maximum dose, as the final appropriate dosage for its new head and neck cancer drug “ficlatuzumab,” which is currently in Phase 3 clinical trials, and is continuing the study. The clinical trial for ficlatuzumab is being conducted by AVEO Oncology, a U.S. subsidiary responsible for LG Chem’s oncology business.
This decision was made after the Independent Data Monitoring Committee (IDMC), based on interim results from the Phase 3 trial (FIERCE-HN) of ficlatuzumab, recommended that the clinical trial proceed using 20mg/kg, the maximum of the two tested doses, as the final selected dosage.
The trial targets patients with human papillomavirus (HPV) negative head and neck cancer who have previously received platinum-based chemotherapy and immune checkpoint inhibitors either sequentially as monotherapy or in combination. It compares the efficacy of a combination therapy of ficlatuzumab and cetuximab with that of a placebo plus cetuximab. The plan is to enroll more than 410 patients (up to 500) and evaluate overall survival (OS), defined as the period from initiation of treatment until death. Subject recruitment is currently underway in multiple countries, including Korea, the United States, and European nations.
Ficlatuzumab is a monoclonal antibody-based targeted anticancer drug that inhibits the activity of hepatocyte growth factor (HGF), which is involved in tumor growth and metastasis.
Julie E. Bauman, MD, director of the George Washington University Cancer Center and principal investigator of the trial, said, “This is a meaningful moment that brings us one step closer to confirming the potential clinical benefits of ficlatuzumab-based combination therapy,” adding, “With the determination of the optimal dosage, the clinical trial is expected to progress more rapidly.”
Son Ji-woong, head of LG Chem’s Life Sciences Business Division, stated, “The company is committed to improving cancer treatment through the development of innovative medicines,” and emphasized, “Building on this meaningful achievement, every effort will be made to establish the clinical value of ficlatuzumab.”
Kim Min-beom
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
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