India Pharma Outlook Team | Thursday, 23 October 2025
Johnson & Johnson announced impressive outcomes for a subcutaneous formulation of amivantamab (Rybrevant) which achieved a 45% overall response rate (ORR) in individuals with advanced head and neck squamous cell carcinoma (HNSCC).
Results in the Phase 1b/2 OrigAMI-4 study were shared at the European Society for Medical Oncology (ESMO) Congress 2025. The patients included in this ongoing study had recurrent or metastatic HNSCC not associated with HPV whose disease progressed after treatment with platinum-based chemotherapy and PD-1/PD-L1 checkpoint inhibitors.
With an ORR of 45%, Rybrevant appears to be an advantage in the challenging treatment paradigm exhibited by this unfortunate group of patients.
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The results of the study show patients achieved responses quickly, with a median time to first response of 6.4 weeks, and durable, with the duration of response being a median of 7.2 months. "These results represent one of the most encouraging response rates we’ve seen in this difficult-to-treat setting," stated Professor Kevin Harrington of The Institute of Cancer Research and The Royal Marsden Hospital, London.
The safety profile of subcutaneous amivantamab was consistent with previous studies, and there were no new safety optimizations. Adverse events included fatigue (31%), hypoalbuminemia (31%), and stomatitis (23%). Only 2% of patients discontinued due to treatment-related events.
Kiran Patel, Vice President of Johnson & Johnson Innovative Medicine, stated that the data reinforce Rybrevant’s potential in treating solid tumors resulting from EGFR and MET pathways. The company plans to move the therapy into Phase 3, potentially in combination with other therapies for first-line HNSCC.
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