–  Global enrollment continues in the Phase 3 registrational study
following the planned first interim analysis for patients with HPV-
negative recurrent or metastatic head and neck squamous cell
carcinoma (R/M HNSCC) –

–  20mg/kg dose of ficlatuzumab selected for the combination arm of
ficlatuzumab and cetuximab –

 AVEO Oncology, an LG Chem company, (AVEO) announced  that the 20mg/kg dose of ficlatuzumab was selected for the combination arm of the Phase 3 registrational FIERCE-HN clinical trial. This dose selection decision follows the recommendation of the Independent Data Monitoring Committee and alignment with the U.S. Food & Drug Administration. The ongoing FIERCE-HN trial continues to enroll patients with human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) with the aim to enroll 410 to 500 patients.

FIERCE-HN is a global, multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial evaluating ficlatuzumab in combination with ERBITUX^® (cetuximab), an anti-epidermal growth factor receptor (EGFR) antibody, as compared to placebo plus cetuximab in patients with human papillomavirus (HPV)-negative recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Ficlatuzumab is AVEO's investigational antibody that targets hepatocyte growth factor (HGF).

"This is a significant milestone for AVEO, as we are dedicated to improving patient outcomes through novel clinical research," said Michael P. Bailey, President and CEO of AVEO. "The selection of the ficlatuzumab dose in combination with cetuximab advances us towards understanding the potential clinical value of this combination in a patient population that has limited effective treatment options available to them today."

"Today's announcement is a defining moment and one that brings us one step closer to determining the potential clinical benefit of the combination of ficlatuzumab and cetuximab in this underserved population," commented Julie E. Bauman, MD, MPH. Dr. Bauman is the Director of the George Washington Cancer Center and Associate Dean of Cancer and Professor of Medicine at the George Washington School of Medicine & Health Sciences as well as the principal investigator of the FIERCE-HN clinical trial. "While I remain a blinded investigator, identifying the optimal dose is a significant inflection point for the clinical trial. We are keen on completing enrollment and continuing to advance the FIERCE-HN study."

In addition, at the upcoming Multidisciplinary Head and Neck Cancers Symposium being held February 19-21, 2026, in Palm Desert, California, Dr. Bauman will be presenting a Trials in Progress poster: FIERCE-HN: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ficlatuzumab (HGF/cMET MAb) in Combination with Cetuximab in Patients with Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma (HNSCC).