CHICAGO — Results from an international trial showed that amivantamab shrank or eliminated tumors in 43 of 102 patients with head and neck cancer. The findings will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

The trial enrolled patients across 11 countries who had head and neck cancers not associated with human papillomavirus (HPV) positive oropharyngeal squamous cell carcinoma. Among those treated, 28 experienced tumor shrinkage and 15 achieved complete eradication. Patients lived a median of 12.5 months after starting treatment.

Amivantamab is a triple-action therapy that blocks EGFR and MET proteins while also activating the immune system to attack tumors. Developed by Johnson & Johnson, the drug is administered as a subcutaneous injection once every three weeks rather than through an intravenous drip. It is currently being studied in approximately 60 clinical trials, primarily for lung cancer but also for colorectal, brain, and gastric cancers.

Most side effects from amivantamab were mild to moderate, and fewer than one in 10 patients discontinued treatment due to adverse reactions. "These are unprecedentedly strong responses in patients whose disease has become resistant to both chemotherapy and immunotherapy," said Kevin Harrington, professor in biological cancer therapies at the Institute of Cancer Research, London. "This is a group of patients for whom treatment options are extremely limited, so seeing this level of benefit is very striking."

Carl Walsh, 56, was diagnosed with tongue cancer in May 2024 and joined the OrigAMI-4 trial at the Royal Marsden in July 2025 after initial treatments failed. "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 17th 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," Walsh said.

Kristian Helin, chief executive of the Institute of Cancer Research, called the results promising. "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," he said.