Janssen-Cilag International NV, part of Johnson & Johnson, has announced encouraging results from the phase 1b/2 OrigAMI-4 study of subcutaneous amivantamab monotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) unrelated to HPV.
Presented at the European Society for Medical Oncology Congress 2025, the data revealed a 45 percent overall response rate in patients whose disease had progressed after checkpoint inhibitor and platinum-based chemotherapy.
Responses were rapid, with a median time to first response of 6.4 weeks, and durable, with a median duration of response of 7.2 months. Tumour shrinkage was observed in 82 percent of patients.
Professor Kevin Harrington, Professor in Biological Cancer Therapies at The Institute of Cancer Research, Royal Marsden Hospital, London, and primary study investigator, said: “Patients with recurrent or metastatic head and neck cancer face an aggressive disease that significantly impacts their quality of life.
“These results represent one of the most encouraging response rates we’ve seen in this difficult-to-treat setting, with durability that could meaningfully extend the time patients live without their disease progressing.”
Henar Hevia, Senior Director, EMEA Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine, explained: “These findings from the OrigAMI-4 study demonstrate the potential of amivantamab to help shift the treatment paradigm for people with recurrent or metastatic head and neck squamous cell carcinoma, who may otherwise face a devastating outlook.”
Kiran Patel, Vice President, Global Head, Solid Tumour Clinical Development and Diagnostics, Johnson & Johnson Innovative Medicine, said: “These data highlight the broader potential of amivantamab-based therapies across solid tumours where the EGFR and/or MET pathways are activated.”
A phase 3 OrigAMI-5 study is now underway to evaluate first-line SC amivantamab in combination therapy.
