J&J reports pivotal Phase 1b/2 results for RYBREVANT FASPRO in head and neck cancer

Johnson & Johnson said pivotal Phase 1b/2 data for subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) showed durable activity in advanced head and neck cancer, a setting where treatment options remain limited.

The company said the OrigAMI-4 study enrolled 102 patients with recurrent or metastatic head and neck squamous cell carcinoma who had already been treated with immunotherapy and platinum-based chemotherapy. The trial excluded patients with HPV-positive oropharyngeal cancer.

According to J&J, the confirmed overall response rate was 42%, and more than one-third of responders achieved complete responses. Median duration of response had not been reached at a median follow-up of 11.8 months.

J&J said the data were presented at the 2026 American Society of Clinical Oncology annual meeting and published at the same time in the Journal of Clinical Oncology.

The company also said it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration for subcutaneous amivantamab in head and neck cancer. That filing sets up the next regulatory step, although the agency has not yet taken action.

The readout adds a new potential use case for RYBREVANT FASPRO beyond J&J’s existing oncology portfolio. For clinicians, the key questions now are whether the benefit holds up across broader practice settings and how the safety profile, durability and subgroup outcomes will look as more independent analysis emerges.