OrigAMI-4 study shows strong tumor responses in patients with recurrent or metastatic head and neck cancer after standard treatments fail. Johnson & Johnson has announced promising clinical results for its investigational therapy RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) in patients with advanced head and neck squamous cell carcinoma (HNSCC), a disease where treatment options remain limited once standard therapies stop working.
The findings come from the pivotal Phase 1b/2 OrigAMI-4 study, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026. The study evaluated patients with recurrent or metastatic HNSCC whose disease had progressed despite prior treatment with both immunotherapy and chemotherapy.
Significant Responses Observed
According to the company, treatment with subcutaneous RYBREVANT FASPRO achieved a 42% confirmed overall response rate, meaning nearly half of the treated patients experienced a measurable reduction in tumor size. Notably, more than one-third of responding patients achieved a complete response, indicating no detectable signs of cancer following treatment.
Researchers also reported that responses appeared rapidly and remained durable over time. At the time of analysis, the median duration of response had not yet been reached, suggesting that many patients continued to benefit from therapy during follow-up.
Addressing a Major Unmet Need
Head and neck squamous cell carcinoma is one of the most common forms of head and neck cancer, affecting areas such as the mouth, throat, and voice box. While advances in immunotherapy have improved outcomes for some patients, many eventually experience disease progression. Survival rates remain poor once the cancer becomes recurrent or metastatic.
Current treatment options available after immunotherapy and chemotherapy generally produce modest response rates, highlighting the need for more effective therapies. Johnson & Johnson noted that existing treatments rarely achieve complete responses in this patient population.
Regulatory Momentum Builds
The positive data further strengthen the case for RYBREVANT FASPRO in head and neck cancer. Earlier this year, the therapy received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for certain patients with advanced head and neck cancer, a designation intended to accelerate the development of treatments that may offer substantial improvement over existing options.
Johnson & Johnson has also submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of the therapy for this indication.
Expanding the Role of Amivantamab
RYBREVANT FASPRO is already approved for specific forms of EGFR-mutated non-small cell lung cancer and is being investigated across multiple solid tumors. The latest findings suggest that the therapy's potential may extend beyond lung cancer and into difficult-to-treat head and neck malignancies.
If approved, the therapy could provide a much-needed treatment alternative for patients with recurrent or metastatic head and neck cancer who have exhausted currently available options, offering hope for improved outcomes in a setting where prognosis remains challenging.
