- Subcutaneous amivantamab achieved a 45% overall response rate in recurrent or metastatic head and neck cancer.
- Tumor shrinkage was observed in 82% of patients, with a median response duration of 7.2 months.
- The study involved 86 patients, with common adverse events including fatigue and stomatitis.
- Further studies are planned with Phase 3 OrigAMI-5 evaluating first-line treatment options.
Study Overview
The Phase 1b/2 OrigAMI-4 study evaluated the efficacy and safety of subcutaneous amivantamab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) unrelated to HPV. This study followed disease progression after treatment with a checkpoint inhibitor and platinum-based chemotherapy.
Key Findings
Subcutaneous amivantamab achieved a 45% overall response rate in 38 efficacy-evaluable patients. Tumor shrinkage was observed in 82% of patients, with a median response duration of 7.2 months. The median progression-free survival was 6.8 months, while median overall survival had not yet been reached.
Patient Impact
Patients with R/M HNSCC have limited treatment options and poor outcomes after disease progression on existing therapies. The study highlights the potential of subcutaneous amivantamab to provide new treatment options for these patients, targeting EGFR and MET pathways while engaging the immune system.
Safety Profile
The safety-evaluable population included 86 patients, with the safety profile consistent with prior studies. Common treatment-emergent adverse events were fatigue, hypoalbuminemia, and stomatitis. Administration-related reactions were mild to moderate, with no severe events reported.
Future Research
Based on these results, further studies are planned, including the Phase 3 OrigAMI-5 study. This study will evaluate first-line treatment with subcutaneous amivantamab combined with pembrolizumab and carboplatin versus 5-fluorouracil plus pembrolizumab and platinum-based chemotherapy in patients with HPV-unrelated R/M HNSCC.
