Johnson & Johnson announces new results from Phase 1b/2 OrigAMI-4 study

Johnson & Johnson announced new results from the Phase 1b/2 OrigAMI-4 study evaluating the efficacy and safety of subcutaneous, SC, amivantamab monotherapy in patients with human papillomavirus, HPV,-unrelated, recurrent or metastatic head and neck squamous cell carcinoma, R/M HNSCC, after disease progression on a checkpoint inhibitor and platinum-based chemotherapy. Data were presented during a mini-oral session at the European Society for Medical Oncology, ESMO, 2025 Congress. In Cohort 1 of the OrigAMI-4 study, treatment with SC amivantamab resulted in an overall response rate of 45 percent in 38 efficacy-evaluable patients with R/M HNSCC unrelated to HPV with disease progression on or after a PD-1 or PD-L1 checkpoint inhibitor and platinum-based chemotherapy. Responses occurred quickly, with a median time to first response of 6.4 weeks, and were durable, with a median duration of response of 7.2 months. Tumor shrinkage of target lesions was observed in 82 percent of patients after 8.3 months follow-up.1 Median progression-free survival was 6.8 months, while median overall survival had not yet been reached.