AVEO Oncology (AVEO) announced enrollment of the first patient in the FIERCE-HN trial, a global, multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating ficlatuzumab in combination with ERBITUX® (cetuximab), an anti-EGFR antibody, 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). The U.S. Food and Drug Administration designated the investigation of ficlatuzumab and ERBITUX® (cetuximab) a Fast Track development program for relapsed/recurrent HNSCC in September 2021.

That designation followed AVEO?s June 2021 announcement of positive results from a randomized phase 2 study of ficlatuzumab alone or in combination with cetuximab in patients with pan-refractory, metastatic HNSCC. In that study, patients with HPV-negative disease, a subgroup normally associated with poorer outcomes, who received the ficlatuzumab and cetuximab combination demonstrated an overall response rate of 38% versus 0% in the HPV positive subgroup, including 13% of HPV-negative patients with complete responses. The FIclatuzumab in combination with ERBITUX® (cetuximab) Clinical Evaluation in Head and Neck cancer patients (FIERCE-HN trial) is designed to initially compare the efficacy and safety of two dose levels of ficlatuzumab plus cetuximab and then will proceed to a registrational stage to compare the optimal dose level to a control arm of placebo plus cetuximab in participants with HPV-negative R/M HNSCC.

The trial is open to adults with a primary diagnosis of R/M HNSCC. Eligible participants must have failed prior therapy with an anti-programmed cell death protein 1, also known as PD-1, or programmed cell death ligand 1, also known as PD-L1, immune checkpoint inhibitor and with platinum-based chemotherapy, administered in combination or sequentially. Failure of prior treatment may be due to disease progression or intolerance to treatment.