Dr Barbara Burtness speaks to ecancer about the OrigAMI-5 study.

She highlights that recurrent and/or metastatic head and neck squamous cell carcinoma carries a poor prognosis, with current first-line treatments such as pembrolizumab combined with platinum-based chemotherapy yielding limited response rates.

The ongoing phase 3 OrigAMI-5 trial is investigating whether adding subcutaneous amivantamab to pembrolizumab and carboplatin improves outcomes compared with the current standard of care regimen of pembrolizumab plus platinum chemotherapy with or without 5-fluorouracil.

She says that this global, randomised study will enroll approximately 500 patients with HPV-unrelated R/M HNSCC who have not received prior treatment in the recurrent/metastatic setting. Participants are stratified by PD-L1 expression and performance status.

The primary endpoints are objective response rate and overall survival, with secondary measures including progression-free survival, duration of response, patient-reported outcomes, and safety. This study aims to determine whether dual EGFR-MET targeting with amivantamab can enhance treatment efficacy and improve survival outcomes in a population with significant unmet clinical need.