AVEO Oncology Completes First Analysis of FIERCE-HN Study for Head and Neck Cancer Treatment

AVEO Oncology's Milestone in FIERCE-HN Study

AVEO Oncology, a subsidiary of LG Chem, has recently reached a significant milestone in the global Phase 3 FIERCE-HN clinical trial. This study is specifically designed for patients suffering from recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who are HPV-negative. The company has announced that a dose of 20 mg/kg of ficlatuzumab has been selected for the trial's combination arm, a decision following a recommendation from the Independent Data Monitoring Committee and in alignment with the U.S. Food and Drug Administration regulations.

The FIERCE-HN Trial

The FIERCE-HN trial is a randomized, multicenter, double-blind, placebo-controlled study aimed at assessing the efficacy of ficlatuzumab in combination with ERBITUX® (cetuximab), an established anti-epidermal growth factor receptor (EGFR) antibody. The objective of this trial is to evaluate whether the combination can provide a significant advantage over placebo plus cetuximab alone, particularly in a patient demographic that has limited effective treatment options.

Michael P. Bailey, President and CEO of AVEO, expressed the importance of this milestone, stating, "We are committed to enhancing patient outcomes through innovative clinical research. The selection of this combination reflects our progress in defining the potential benefits it could offer for a patient population facing unmet medical needs."

Significance of the Study

The collaboration with Eli Lilly and Company further strengthens the study, with Lilly supplying cetuximab for all North American trial sites. As of now, the recruitment for the trial is ongoing, aiming to enroll between 410 and 500 participants—all adults with a primary diagnosis of R/M HNSCC. Notably, these participants must have previously failed treatment with both chemotherapy and an anti-PD-1 inhibitor, which are common courses for this type of cancer.

Dr. Julie E. Bauman, who is the Director of the George Washington Cancer Center and a principal investigator of the FIERCE-HN trial, highlighted the significance of determining the optimal dose for this trial, calling it a defining moment in advancing research for these underserved patients. She stated, “Identifying the optimal dose is a significant inflection point for the clinical trial. Our goal now is to complete enrollment successfully and proceed with the study effectively.”

Upcoming Presentation

The implications of the FIERCE-HN trial and its progress will be showcased at the Multidisciplinary Head and Neck Cancers Symposium from February 19-21, 2026, in Palm Desert, California. Dr. Bauman will present a poster detailing the trial, focusing on the potential of ficlatuzumab combined with cetuximab for treating R/M HNSCC.

About AVEO Oncology

AVEO Oncology, based in Boston, is an oncology-focused biopharmaceutical firm that strives to deliver life-enhancing medicines for cancer patients. Their product portfolio includes FOTIVDA® (tivozanib), which has been developed for patients suffering from advanced renal cell carcinoma. Beyond ficlatuzumab, AVEO is exploring other investigational programs aimed at addressing various cancer-related needs.

This latest advancement highlights AVEO's commitment to transforming cancer treatment and addressing gaps in therapy options for patients with serious conditions. As clinical trials progress, local and global communities eagerly await the results that may pave the way for new therapeutic strategies in oncology.