NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced new data from Cohort 5 of the Phase 1b/2 OrigAMI-4 study showing deep and durable responses with first-line subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) combined with a PD-1 inhibitor and fixed-duration carboplatin chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Among patients with HNSCC excluding human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC), the regimen achieved a confirmed overall response rate (ORR) of 77%, including complete responses in 14% of patients. Tumor shrinkage was observed in all evaluable patients, while nearly two-thirds of responses remained ongoing at a median follow-up of 10.6 months.
The company said responses were both deep and durable, with 65% of responses still ongoing at the clinical data cutoff, underscoring the potential of the investigational regimen in the first-line treatment setting.
The findings support continued evaluation of the RYBREVANT FASPRO-based regimen in the ongoing pivotal Phase 3 OrigAMI-5 trial, which is assessing the treatment as a first-line option for patients with recurrent or metastatic HNSCC.
Johnson & Johnson noted that the results also reinforce the therapeutic rationale for dual targeting of EGFR and MET, two pathways implicated in tumor growth and treatment resistance in an estimated 80% to 90% of HNSCC cases. The company believes simultaneous inhibition of these drivers may help improve outcomes in a disease with significant unmet medical need.
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