The Institute of Cancer Research Reports Promising Tumour Response Results for Amivantamab in Advanced Head and Neck Cancer

The Institute of Cancer Research Reports Promising Tumour Response Results for Amivantamab in Advanced Head and Neck Cancer

(IN BRIEF) The Institute of Cancer Research, London, has presented encouraging results from the phase Ib/II OrigAMI-4 clinical trial, showing that the targeted immunotherapy drug amivantamab shrank tumours in 42 per cent of patients with recurrent and/or metastatic head and neck cancer whose disease had progressed after both immunotherapy and platinum-based chemotherapy. The study involved 102 patients across 55 hospitals in 11 countries and focused on a particularly difficult-to-treat group, excluding HPV-positive oropharyngeal squamous cell carcinoma. Doctors recorded tumour shrinkage in 43 patients, including 15 complete responses and 28 partial responses, while median overall survival reached 12.5 months. Delivered as a small under-the-skin injection once every three weeks, amivantamab blocks EGFR and MET cancer pathways while also helping activate the immune system against tumours. Researchers said the results provide strong support for continued clinical development, including the ongoing phase III OrigAMI-5 trial, which could help determine whether the treatment may benefit thousands of patients in the UK, Europe and worldwide.

(PRESS RELEASE) LONDON, 1-Jun-2026 — /EuropaWire/ — The Institute of Cancer Research, London (ICR), London, has reported promising clinical trial results showing that a targeted immunotherapy injection helped shrink tumours in more than one third of patients with recurrent and/or metastatic head and neck cancer whose disease had stopped responding to standard treatments. The findings, presented at the American Society of Clinical Oncology Annual Meeting, come from the phase Ib/II OrigAMI-4 clinical trial and point to the potential of amivantamab as a new option for a patient group with very limited remaining therapies.

The results showed tumour shrinkage in 42 per cent of patients treated with amivantamab, based on blinded independent central review, a process in which external experts assess outcomes without knowing which treatment each patient received. Researchers said this approach strengthens the reliability of the findings and provides strong support for further development of the drug in head and neck cancer.

The trial focused on patients with recurrent or metastatic head and neck squamous cell carcinoma whose cancer had continued to progress after both immunotherapy and platinum-based chemotherapy. It excluded patients with HPV-positive oropharyngeal squamous cell carcinoma, as non-HPV-related head and neck cancers are generally more difficult to treat and often respond less well to standard therapies.

Cohort one of the OrigAMI-4 study included 102 patients across 55 hospitals in 11 countries. All participants in this part of the study received amivantamab as a single treatment. The UK team was led by Professor Kevin Harrington of The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.

Among the patients treated, doctors recorded tumour shrinkage in 43 people. This included 15 patients whose tumours disappeared completely, known as complete responses, and 28 patients whose tumours shrank significantly, known as partial responses. Patients receiving amivantamab lived for a median of 12.5 months after starting treatment, despite having a form of cancer associated with poor outcomes once standard options are no longer effective.

Responses to the treatment were seen within around six weeks, while patients experienced a median period of just over six and a half months before their cancer began to grow again.

Amivantamab, developed by Johnson & Johnson, is a bispecific monoclonal antibody already approved for several types and treatment stages of lung cancer. The drug targets two important cancer pathways: EGFR, a protein that helps tumours grow, and MET, a pathway cancer cells can use to evade treatment. It also supports the immune system in attacking tumour cells.

The treatment is delivered as a small injection under the skin rather than through an intravenous drip, making it faster and more convenient for patients and easier to provide in outpatient clinics. It is administered once every three weeks. Most reported side effects were mild to moderate, and fewer than one in 10 patients stopped treatment because of side effects.

Researchers said that if the benefits are confirmed in larger studies, including the ongoing phase III OrigAMI-5 trial, amivantamab could potentially benefit thousands of patients in the UK and Europe each year, as well as many more worldwide.

Professor Kevin Harrington, Professor in Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Oncologist at The Royal Marsden NHS Foundation Trust, described the responses as unprecedentedly strong in patients whose disease had become resistant to both chemotherapy and immunotherapy. He said the findings provide strong support for advancing amivantamab into earlier stages of relapsed or metastatic head and neck cancer and have helped support the launch of the OrigAMI-5 registrational trial.

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said the study demonstrates how rigorous cancer research can help drive meaningful progress for patients with very limited treatment options. He noted that achieving this level of tumour response and encouraging survival outcomes in a difficult-to-treat group represents an important step forward.

The trial has already made a difference for patients such as Carl Walsh, 56, from Birmingham, who was diagnosed with tongue cancer in May 2024 and joined OrigAMI-4 at The Royal Marsden in July 2025. After chemotherapy and immunotherapy were unsuccessful, he began treatment through the trial and is now on his seventeenth cycle. He said the treatment has helped reduce swelling and pain, improved his ability to speak and eat, and allowed him to feel able to live a normal life again.

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SOURCE: The Institute of Cancer Research