05:31 AM EDT, 10/20/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Sunday that its subcutaneous formulation of amivantamab showed an overall response rate of 45% in a phase 1b/2 study involving patients with recurrent or metastatic head and neck squamous cell carcinoma unrelated to human papillomavirus, following disease progression after prior checkpoint inhibitor and platinum-based chemotherapy.
In cohort 1 of the study, the drugmaker said the responses to the subcutaneous treatment, delivered via a five-minute manual injection, occurred quickly, with a median time to first response of 6.4 weeks.
Responses were durable, with a median duration of 7.2 months, the company said, adding that tumor shrinkage was observed in 82% of patients after a median follow-up of 8.3 months.
Median progression-free survival was 6.8 months, while median overall survival has not yet been reached, it added.
Johnson & Johnson ( JNJ ) said the safety profile remained consistent with prior studies of subcutaneous amivantamab, with no new safety concerns reported.
Based on the results, Johnson & Johnson ( JNJ ) said it is advancing to a phase 3 trial evaluating subcutaneous amivantamab in combination with pembrolizumab and carboplatin as a first-line treatment, comparing it to a standard therapy of 5-fluorouracil, pembrolizumab, and platinum-based chemotherapy.