A groundbreaking clinical trial led by the Institute of Cancer Research (ICR) in London has revealed “unprecedentedly strong responses” to a new injectable drug, amivantamab, which has eliminated entire tumors in patients with recurrent or metastatic head and neck cancer that had stopped responding to conventional treatments.
The international study found that 42% of patients experienced significant tumor shrinkage, with 15 participants seeing complete tumor disappearance. The trial included 102 individuals whose cancers had progressed despite chemotherapy and immunotherapy, highlighting amivantamab’s potential to benefit a group of patients with very limited options.
Unlike most cancer treatments administered via intravenous drips, amivantamab is delivered as a small injection every three weeks, making it more convenient and easier to administer in outpatient settings.
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One inspiring patient, Carl Walsh, 56, from Birmingham, shared how the treatment transformed his life following a tongue cancer diagnosis in May 2024. After unsuccessful chemotherapy and immunotherapy, he joined the trial at The Royal Marsden in July 2025. Carl reported that the drug significantly reduced swelling and pain, improving his ability to speak and eat, and alleviating many of the harsh side effects he endured during chemotherapy. He stated, “I now feel able to live a normal life.”
Professor Kevin Harrington, a leading oncologist at The Royal Marsden and ICR, emphasized the significance of these results: “These are unprecedentedly strong responses in patients whose disease has become resistant to both chemotherapy and immunotherapy. This treatment has the potential to benefit many thousands of patients each year.”
Head and neck cancer ranks as the sixth most common cancer worldwide, with approximately 12,800 new diagnoses annually in the UK alone. Participants in the study came from 55 hospitals across 11 countries and received only amivantamab, a bispecific monoclonal antibody developed by Johnson & Johnson.
Amivantamab works by targeting two key signals that promote tumor growth—EGFR (Epidermal Growth Factor Receptor) and MET pathways—while also enhancing the immune system’s ability to attack the cancer. Patients began showing responses within about six weeks, with a median duration of response lasting over six and a half months. Despite their advanced cancer stage, participants survived a median of 12.5 months after starting treatment.
Adverse effects were generally mild to moderate, with fewer than 10 patients discontinuing due to side effects, underscoring the drug’s manageable safety profile.
Professor Kristian Helin, CEO of the ICR, hailed the study as a major breakthrough: “Achieving this level of tumor response and encouraging survival outcomes in such a challenging-to-treat group represents a significant step forward.”
Although amivantamab is already approved for various lung cancer subtypes, this study marks a critical advance for difficult-to-treat head and neck cancers, particularly those not caused by HPV, which typically show poorer responses to standard therapies.
The promising results from the OrigAMI-4 trial are set to be presented at the upcoming American Society of Clinical Oncology conference.