EGFR

Johnson & Johnson presented promising Phase 1b/2 OrigAMI-4 data at ESMO 2025 on subcutaneous amivantamab for recurrent/metastatic HPV-unrelated head and neck squamous cell carcinoma (R/M HNSCC) after checkpoint inhibitor and platinum therapy failure. The study showed a 45% overall response rate and tumor shrinkage in 82% of patients, surpassing current therapy benchmarks. SC delivery allows for rapid injection, reducing clinic time. The ongoing Phase 3 OrigAMI-5 study will evaluate amivantamab with pembrolizumab and carboplatin as a first-line treatment.

Bicara Therapeutics presented positive Phase 1/1b trial data for ficerafusp alfa, a bifunctional antibody, combined with pembrolizumab in first-line recurrent/metastatic head and neck cancer. The results, particularly in HPV-negative patients, showed significant antitumor activity, including a median duration of response of 21.7 months, median overall survival of 21.3 months, and a two-year overall survival rate of 46%. The data supports the advancement of the FORTIFI-HN01 pivotal trial.