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Cancer metastasis

Johnson & Johnson Announces Promising Results for Amivantamab in Head and Neck Cancer Study

Strategic Insights

— 2 min read

The European Society for Medical Oncology (ESMO) 2025 Congress saw the presentation of data from the Phase 1b/2 OrigAMI-4 study evaluating the efficacy and safety of subcutaneous amivantamab monotherapy in patients with human papillomavirus (HPV)-unrelated, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after disease progression on a checkpoint inhibitor and platinum-based chemotherapy. The study showed a promising 45% overall response rate, with responses occurring quickly and being durable. The safety profile was consistent with prior studies, with no new safety signals observed.

Key Takeaways:

  • The OrigAMI-4 study evaluated the efficacy and safety of subcutaneous amivantamab monotherapy in 38 efficacy-evaluable patients with R/M HNSCC unrelated to HPV who had disease progression on or after a PD-1 or PD-L1 checkpoint inhibitor and platinum-based chemotherapy.
  • The overall response rate (primary endpoint) was 45% in patients treated with SC amivantamab, with a median time to first response of 6.4 weeks and a median duration of response of 7.2 months.
  • The safety profile was consistent with prior SC amivantamab monotherapy studies, with no new safety signals observed. The most common treatment-emergent adverse events were fatigue (31%), hypoalbuminemia (31%), and stomatitis (23%).
  • Johnson & Johnson is initiating further study of SC amivantamab in head and neck cancer with the Phase 3 OrigAMI-5 study, which is evaluating first-line SC amivantamab with pembrolizumab and carboplatin versus 5-fluorouracil (5FU) plus pembrolizumab and platinum-based chemotherapy (cisplatin or carboplatin) in patients with HPV-unrelated R/M HNSCC.
  • The findings add to the evidence supporting the role of RYBREVANT-based treatments across multiple solid tumors, including non-small cell lung cancer, colorectal cancer, and HNSCC.

Statistics:

  • 45% overall response rate in patients treated with SC amivantamab.
  • Median time to first response: 6.4 weeks (range, 5.7-18.3).
  • Median duration of response: 7.2 months (95% CI, 5.3-not estimable [NE]).
  • 82% tumor shrinkage of target lesions after 8.3 months follow-up.
  • Median progression-free survival: 6.8 months (95% CI, 4.2-9.0).
  • Median overall survival had not yet been reached (95% CI, 7.7-NE).

Sources:

  • European Society for Medical Oncology (ESMO) 2025 Congress (Oral Abstract #1327MO)
  • Johnson & Johnson press release (2025 NOV 4)
  • Original study: OrigAMI-4 study evaluating the efficacy and safety of subcutaneous amivantamab monotherapy in patients with HPV-unrelated, recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after disease progression on a checkpoint inhibitor and platinum-based chemotherapy.

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