Johnson & Johnson has reported a confirmed overall response rate (ORR) of 77% with a combination regimen containing RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) in previously untreated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), excluding HPV-associated oropharyngeal cancer. The findings come from Cohort 5 of the Phase 1b/2 OrigAMI-4 study.
The regimen combined subcutaneous amivantamab with pembrolizumab, a PD-1 inhibitor, and a fixed-duration course of carboplatin chemotherapy. Among 22 evaluable patients in the specified HNSCC subgroup, 77% had a confirmed tumour response, including 14% who achieved a complete response and 64% who had a partial response. Tumour shrinkage was observed in all evaluable patients in this subgroup.
At a median follow-up of 10.6 months, 65% of responses remained ongoing. The median time to response was 9.4 weeks. The company also reported that median overall survival had not been reached, while 77% of patients were alive at one year.
The most frequently reported adverse events included anaemia (73%), hypoalbuminaemia (63%), thrombocytopenia (63%) and stomatitis (57%). Administration-related reactions associated with subcutaneous amivantamab occurred in 13% of patients, with no Grade 3 or higher events reported in the study cohort.
The results were presented at the European Society for Medical Oncology (ESMO) Congress 2026 and support continued evaluation in the ongoing Phase 3 OrigAMI-5 study. A separate application for RYBREVANT FASPRO in later-line head and neck cancer is under Priority Review by the US Food and Drug Administration.
Amivantamab is a bispecific antibody designed to target epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET), pathways associated with tumour growth and treatment resistance. The reported response rate applies to the specified subgroup in this early-phase study; further evaluation is needed to establish the regimen’s role in first-line treatment.
