On October 20, 2025, Johnson & Johnson announced promising results from the Phase 1b/2 OrigAMI‑4 study of subcutaneous amivantamab (amivantamab‑vmjw) in patients with HPV‑unrelated, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who had progressed on checkpoint inhibitor and platinum‑based chemotherapy. The study enrolled 38 efficacy‑evaluable patients and reported an overall response rate of 45 % (95 % CI 29‑62), with a median duration of response of 7.2 months and tumor shrinkage observed in 82 % of patients after 8.3 months of follow‑up. Median progression‑free survival was 6.8 months and overall survival had not yet been reached at the time of the announcement.
The safety profile was consistent with prior subcutaneous amivantamab studies, with no new safety signals. The most common treatment‑emergent adverse events were fatigue (31 %), hypoalbuminemia (31 %) and stomatitis (23 %). Administration‑related reactions occurred in 7 % of patients, all mild to moderate, and only 2 % discontinued treatment due to adverse events.
The subcutaneous formulation delivers a five‑minute manual injection, offering increased patient convenience compared to the intravenous RYBREVANT platform. The data support the broader application of the bispecific antibody across solid tumors and justify the initiation of a Phase 3 OrigAMI‑5 study that will evaluate SC amivantamab combined with pembrolizumab and carboplatin versus standard chemotherapy in HPV‑unrelated R/M HNSCC.
These results reinforce Johnson & Johnson’s oncology pipeline and expand the potential market for its bispecific antibody platform. The positive efficacy and manageable safety profile may accelerate regulatory submissions and commercial launch timelines, potentially adding a new revenue stream to the company’s high‑growth portfolio.
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