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Johnson & Johnson announced Phase 1b/2 OrigAMI-4 study results demonstrating that subcutaneous RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) produced durable responses in patients with recurrent or metastatic head and neck squamous cell carcinoma. The confirmed overall response rate reached 42%, including complete responses in more than one-third of responders. Median duration of response had not been reached after a median follow-up of 11.8 months, indicating sustained benefits.

The study evaluated subcutaneous amivantamab monotherapy in 102 patients previously treated with immunotherapy and platinum-based chemotherapy, excluding HPV-positive oropharyngeal cancer. Confirmed responses were assessed by blinded independent central review, showing a 42% overall response rate with 15% complete responses and 27% partial responses. Median progression-free survival was 6.8 months, and overall survival reached 12.5 months.

RYBREVANT FASPRO™ targets both EGFR and MET pathways while engaging the immune system, offering a differentiated approach for this aggressive disease. Investigators noted the high response rate and durability suggest potential to improve outcomes for patients with limited treatment options. The safety profile was consistent with prior reports, with most adverse events mild to moderate.

A supplemental Biologics License Application has been submitted to the FDA seeking approval for subcutaneous amivantamab in head and neck cancer, following Breakthrough Therapy Designation. The Phase 3 OrigAMI-5 study is also underway, evaluating subcutaneous amivantamab in combination with carboplatin and pembrolizumab as a first-line treatment for recurrent or metastatic disease.