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A new type of cancer treatment which is given via an injection under the skin has shown early signs of success in patients with advanced head and neck cancer.
Results of the phase Ib/II Orig-AMI 4 clinical trial, presented today at the European Society for Medical Oncology (ESMO) 2025 Congress by scientists from The Institute of Cancer Research, London, have shown that the drug called amivantamab, which is given as a simple injection, could shrink or halt tumour growth.
A difficult-to-treat cancer
Head and neck cancer is the sixth most common cancer worldwide, with around 12,800 new cases each year in the UK alone. It is usually treated with surgery and radiotherapy. However, once the disease spreads or returns, it is generally treated with immunotherapy and platinum-based chemotherapy. If such treatment fails to control the disease, further options are limited – and the only approved targeted therapy, cetuximab, helps a limited number of patients.
The Orig-AMI 4 trial is testing amivantamab, both alone and in combination with other drugs, in people with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) – a difficult-to-treat cancer that often returns after standard therapies.
The trial involved 55 sites in 11 countries around the world, including a team led by Professor Kevin Harrington at The Institute of Cancer Research (ICR) and Royal Marsden NHS Foundation Trust
Next generation drug targets cancer in three ways
Amivantamab, which is being developed by Johnson & Johnson and has already been approved for a type of lung cancer, is a type of treatment called a bispecific monoclonal antibody – a next-generation drug that targets cancer in three ways.
Firstly, it works by blocking EGFR (epidermal growth factor receptor), a protein that helps tumours grow. It also blocks MET, a separate pathway that cancer cells often use to escape treatment. Finally, it helps activate the immune system to attack the tumour.
One group of patients in the study, who had already received both immunotherapy and chemotherapy, were given amivantamab on its own.
Results showed most patients experienced a benefit
The results show that 76 per cent of this group of patients experienced clinical benefit from the therapy, meaning their cancer either shrank or stopped growing.
Responses were seen within six weeks on average and the treatment was generally well tolerated, with most side effects being mild to moderate. The average progression-free survival for patients receiving amivantamab on its own was 6.8 months.
As of July 2025, 53 of the 86 patients in this cohort (62 per cent) were still receiving the new treatment.
Researchers hope the jab will become a new treatment option
Amivantamab is now showing promise in not only lung cancer and head and neck cancer, but also colorectal cancer. Researchers hope this innovative jab could become a new option for patients with few remaining choices.
Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and Consultant Oncologist at The Royal Marsden NHS Foundation Trust, said:
"This is the first time we’ve tested this kind of triple-action therapy for head and neck cancer patients whose disease has returned after treatment. Amivantamab is a ‘smart’ drug that not only blocks two key cancer pathways but also helps the immune system do its job.
"Unlike many cancer treatments that require hours in a hospital chair, amivantamab is given as an injection under the skin. This makes it faster, more convenient, and potentially easier to deliver in outpatient clinics.
"To see this level of benefit for patients who have endured numerous treatments is incredibly encouraging. This could represent a real shift in how we treat head and neck cancer – not just in terms of effectiveness, but also in how we deliver care."
Professor Clare Isacke, Dean of Academic and Research Affairs of The Institute of Cancer Research, London, said:
"These results are a powerful reminder of the urgent need for more effective and accessible treatments for people living with head and neck cancer. This is a disease that often returns aggressively and leaves patients with very few options. The promise shown by amivantamab – particularly its ability to deliver meaningful clinical benefit through an injection under the skin – represents a significant step forward.
"We’re proud to see such innovation emerging from global collaboration and world-class research, and we remain committed to supporting the development of therapies that offer real hope to patients and their families."
'The treatment is working well so far, sometimes I forget that I have cancer'
Carl Walsh, 59, from Birmingham, was diagnosed with tongue cancer in May 2024. He joined the Orig-AMI 4 trial at The Royal Marsden NHS Foundation Trust in July this year.
"Chemotherapy was my first treatment option, but unfortunately, it wasn’t successful. Then I tried immunotherapy, but that also didn’t work as well as hoped. After that, they recommended I join the Orig-AMI 4 trial. I’m now on my 7th cycle of treatment, it’s working well so far and I’m very happy with the progress.
"Before starting the trial, I couldn’t talk properly and eating was difficult but the swelling has gone down a lot, and I’m not in the same amount of pain I used to be in. Sometimes I even forget that I have cancer. The only side effect I’ve experienced so far is minor skin issues, which is a big relief compared to the many side effects I had with chemotherapy."