Core Insights - Johnson & Johnson announced promising results from the Phase 1b/2 OrigAMI-4 study, which evaluated the efficacy and safety of subcutaneous amivantamab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after prior treatments [1][5][6] Study Results - The study reported an overall response rate of 45% in patients with HPV-unrelated R/M HNSCC, with a median time to first response of 6.4 weeks and a median duration of response of 7.2 months [3][4] - Tumor shrinkage was observed in 82% of patients after 8.3 months of follow-up, with a median progression-free survival of 6.8 months [3][4] - The safety profile of subcutaneous amivantamab was consistent with previous studies, with common adverse events including fatigue (31%), hypoalbuminemia (31%), and stomatitis (23%) [4][5] Treatment Context - Patients with R/M HNSCC have limited treatment options and poor outcomes after disease progression on PD-1 or PD-L1 inhibitors and platinum-based chemotherapy, with response rates typically ranging from 10% to 24% [2] - RYBREVANT, the bispecific antibody targeting EGFR and MET, is positioned as a potential treatment option for these patients, highlighting the role of EGFR and MET as key tumor drivers [2][4] Future Directions - Based on the positive results from the OrigAMI-4 study, Johnson & Johnson is initiating the Phase 3 OrigAMI-5 study to further evaluate subcutaneous amivantamab in combination with pembrolizumab and carboplatin [5][6] - The findings support the broader potential of RYBREVANT-based therapies across multiple solid tumors, including non-small cell lung cancer and colorectal cancer [4][6]