RYBREVANT FASPRO combination shows 77% response rate in first-line advanced head and neck cancer

Johnson & Johnson has reported new Phase Ib/II results showing a 77% overall response rate with a RYBREVANT FASPRO-based combination in previously untreated patients with recurrent or metastatic head and neck squamous cell carcinoma.

The findings come from Cohort 5 of the OrigAMI-4 study and were presented in a rapid oral presentation at the 2026 European Society for Medical Oncology Congress.

The investigational regimen combines subcutaneous RYBREVANT FASPRO, also known as amivantamab and hyaluronidase-lpuj, with the PD-1 inhibitor pembrolizumab and a fixed course of carboplatin chemotherapy.

Among patients with forms of head and neck squamous cell carcinoma other than HPV-associated oropharyngeal squamous cell carcinoma, the confirmed overall response rate was 77%.

This included complete responses in 14% of patients and partial responses in 64%.

Tumour shrinkage was observed in all evaluable patients in this group.

Responses occurred after a median of 9.4 weeks, and 65% remained ongoing at a median follow-up of 10.6 months.

Four patients, representing 18%, achieved stable disease, while one patient, or 5%, experienced progressive disease.

Median overall survival had not been reached at the time of analysis, while 77% of patients were alive at one year.

The study analysed patients with HPV-associated oropharyngeal squamous cell carcinoma separately because of known differences in response to EGFR-targeted bispecific treatments.

Among the seven patients in this subgroup, the overall response rate was 29%.

Cohort 5 included 30 patients treated with subcutaneous amivantamab, pembrolizumab and carboplatin. Twenty-nine patients were included in the efficacy analysis after one participant was considered ineligible.

Patients received up to six cycles of carboplatin, while treatment with the combination was administered every three weeks following the initial treatment period.

Subcutaneous amivantamab could be administered in five minutes or less.

RYBREVANT FASPRO is designed to target both EGFR and MET while also engaging the immune system.

Johnson & Johnson said EGFR and MET overexpression is found in around 80% to 90% of head and neck squamous cell carcinoma tumours and may contribute to tumour growth and treatment resistance.

Paul Swiecicki, MD, Associate Professor of Haematology and Oncology at the University of Michigan Rogel Cancer Center, said the depth and durability of the responses support further investigation of subcutaneous amivantamab earlier in the treatment of recurrent or metastatic head and neck cancer.

Yusri Elsayed, MD, MHSc, PhD, Global Therapeutic Area Head of Oncology at Johnson & Johnson, said the results extend the company’s experience with dual EGFR and MET targeting beyond lung cancer and support continued development in head and neck disease.

The safety profile of the combination was consistent with the known profiles of the individual treatments.

The most commonly reported adverse events were anaemia in 73% of patients, hypoalbuminaemia in 63%, thrombocytopenia in 63% and stomatitis in 57%.

Administration-related reactions associated with subcutaneous amivantamab occurred in 13% of patients, with no Grade 3 or higher reactions reported.

The findings support continued evaluation of the regimen in the ongoing Phase III OrigAMI-5 study in the first-line setting.

Johnson & Johnson also has an application for RYBREVANT FASPRO in later-line head and neck cancer under Priority Review with the U.S. Food and Drug Administration.

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Related Topics and Keywords

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