A targeted cancer treatment given via a simple injection under the skin shrank tumours in more than one third of patients with recurrent and/or metastatic head and neck cancer whose disease has stopped responding to standard treatments.
New results from phase Ib/II OrigAMI‑4 clinical trial, by scientists from The Institute of Cancer Research, London, and presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, confirmed tumour shrinkage in 42 per cent of patients treated with the drug amivantamab, alongside encouraging survival outcomes in a group of patients who until now had very limited options. The results, published in the Journal of Clinical Oncology, are based on blinded independent central review (BICR), where outcomes were checked by external experts who did not know which treatment each patient received, helping ensure the results are fair, unbiased, and reliable.
Researchers say the findings provide very strong evidence to support the further development of amivantamab as a potential treatment for head and neck cancer, a disease which affects around 12,800 people in the UK each year and is the sixth most common cancer worldwide.
A hard to treat cancer
The trial focused on people with head and neck cancer, excluding those with human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma. Head and neck cancers not caused by HPV are usually harder to treat and tend to respond less well to standard therapies, making progress in this group particularly important.
Cohort one of the OrigAMI‑4 study involved 102 people with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose cancer had continued to grow despite immunotherapy and platinum‑based chemotherapy.
All patients in this part of the trial, which ran in 55 hospitals in 11 countries, including a team led by Professor Kevin Harrington at The Institute of Cancer Research (ICR) and Royal Marsden NHS Foundation Trust, received amivantamab on its own.
Some tumours disappeared completely
Doctors saw tumours shrink in 43 people including 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 overall after starting treatment, despite having a form of cancer with very poor outcomes, once standard treatments stop working.
Tumour responses were seen within about six weeks, and patients had a median of just over six and a half months before their cancer began to grow again.
Amivantamab, which is being developed by Johnson & Johnson, and has already been approved for multiple subtypes of lung cancer across multiple lines of therapy, is a type of treatment called a bispecific monoclonal antibody.
Blocking key cancer signals
It works by blocking two key signals, EGFR (Epidermal Growth Factor Receptor), a protein that helps tumours grow, and MET, a separate pathway that cancer cells often use to escape treatment. It also has a third beneficial action, by helping to activate the immune system to attack the tumour.
Unlike many cancer treatments, amivantamab is given as a small injection under the skin rather than through an intravenous drip, making treatment quicker and more convenient for patients and significantly easier to deliver in outpatient clinics.
Most side effects of the treatment, which is given once every three weeks, were mild to moderate, and fewer than one in 10 patients stopped treatment because of side effects.
If the benefits seen in this study are confirmed in larger trials, such as the ongoing OrigAMI‑5 phase III trial, it is hoped the treatment could ultimately help many thousands of patients in the UK and Europe each year, and tens of thousands globally.
'A striking level of benefit'
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, said:
“These are unprecedentedly strong responses in patients whose disease has become resistant to both chemotherapy and immunotherapy. This is a group of patients for whom treatment options are extremely limited, so seeing this level of benefit is very striking.
“The results provide very strong supportive evidence for developing amivantamab potentially earlier in relapsed or metastatic head and neck cancer and have helped underpin the launch of a phase III registrational trial, OrigAMI-5. This treatment has the potential to benefit many thousands of patients each year.”
Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said:
“This study demonstrates how the development of new treatments through rigorous cancer research may lead to meaningful advances, even for patients with very limited treatment options. Achieving this level of tumour response and encouraging survival outcomes in such a challenging‑to‑treat group represents a significant step forward.
“At the ICR, we are committed to translating discoveries into treatments that can make a real difference to patients’ lives, and we are proud to see this work helping to advance the next stage of clinical development.”
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‘I now feel able to live a normal life’
Carl Walsh, 56, from Birmingham, was diagnosed with tongue cancer in May 2024 and joined the OrigAMI-4 trial at The Royal Marsden in July 2025.
“I was initially treated with both chemotherapy and immunotherapy, which unfortunately were not successful. At that point, I was recommended for the OrigAMI-4 trial. I’m now on my seventeenth cycle of treatment and I’m very pleased with the progress so far.
“I now feel able to live a normal life. Before starting the trial, I struggled to speak properly and found eating difficult because of the swelling and pain. Since beginning treatment, the swelling has reduced significantly, and my pain levels have improved considerably. I’m also no longer experiencing the same life-impacting side effects that I had during chemotherapy."
