RYBREVANT FASPRO Demonstrates Significant and Durable Efficacy in Heavily Pretreated Advanced Head and Neck Cancer, Submits sBLA to FDA

May 31, 2026Johnson & JohnsonCompany Announces Key Results from Phase 1b/2 OrigAMI-4 Study, Demonstrating Durable Treatment Responses to Subcutaneous Amivantamab and Hyaluronidase-lpuj in Patients with Previously Treated Advanced Squamous Cell Carcinoma of the Head and Neck The confirmed overall response rate was 42%, with more than one-third of responders achieving complete response. At a median follow-up of 11.8 months, the median duration of response had not been reached. The data were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology.

Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA, seeking approval for subcutaneous amivantamab in the treatment of head and neck cancers.

There is a significant unmet need in advanced head and neck cancer, with a five-year survival rate of approximately 15% following recurrence or metastasis, and limited benefit from existing treatment options. Subcutaneous amivantamab targets EGFR and MET, activating the immune system.

OrigAMI - In Cohort 1 of the study, the efficacy of the therapy was evaluated in 102 patients with recurrent or metastatic head and neck cancer, confirming an overall response rate of 42%, a clinical benefit rate of 63%, a median time to first response of 6.6 weeks, and median progression-free survival and overall survival of 6.8 months and 12.5 months, respectively. The safety profile was consistent with previously reported data, with the majority of adverse events being Grade 1 or 2.

Updated results from the Phase 3 OrigAMI-5 study were also presented at the 2026 ASCO Annual Meeting. This study evaluated the efficacy of subcutaneous amivantamab in combination with carboplatin and pembrolizumab as first-line therapy. RYBREVANT FASPRO has been approved in more than 40 countries for the treatment of patients with EGFR-mutated non-small cell lung cancer (NSCLC).

In addition, the article describes the indications and important safety information for RYBREVANT FASPRO and RYBREVANT, including contraindications, warnings and precautions, adverse reactions, etc., as well as drug interactions involving LAZCLUZE.

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