Nearly half of patients with HPV-unrelated recurrent or metastatic head and neck cancer responded to subcutaneous amivantamab, with over three-quarters seeing tumor shrinkage. Presented at ASCO and published in the Journal of Clinical Oncology, the OrigAMI-4 trial results have prompted an FDA supplemental biologics license application. The findings could reshape second- and third-line treatment for this difficult-to-treat population.
A promising new option for a tough-to-treat cancer
Patients with HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who progress after standard immunotherapy and chemotherapy have very few effective options — but new data suggest subcutaneous amivantamab could change that. Results from the phase 1B/2 OrigAMI-4 trial, presented at ASCO and published in the Journal of Clinical Oncology, showed the dual EGFR-MET bispecific antibody delivered rapid and durable responses in this population.
The study enrolled 102 patients who had progressed on a PD-L1 inhibitor and chemotherapy. Responses were consistent across key subgroups, and a supplemental biologics license application has been submitted to the FDA. The drug already holds FDA Breakthrough Therapy Designation for this indication.
By the Numbers:
Why it matters: Current second-line EGFR inhibition yields roughly a 24% response rate and a median OS of 8.6 months. Amivantamab nearly doubles the response rate and pushes survival beyond a year — a meaningful leap for patients with limited options and a high symptom burden.
