A novel triple-action injection has produced “unprecedented” results in an international clinical trial, completely eradicating tumors in a subset of patients with advanced head and neck cancer who had run out of other options.
The treatment, a subcutaneous injection of the drug amivantamab, led to significant tumor shrinkage in more than a third of participants, with some seeing their cancer disappear entirely within weeks.
These “unprecedentedly strong responses” were seen in patients whose disease had become resistant to both chemotherapy and immunotherapy, two of the most powerful standard treatments.
“This is a group of patients for whom treatment options are extremely limited, so seeing this level of benefit is very striking.”
— Kevin Harrington, Professor of Biological Cancer Therapies at the Institute of Cancer Research, London (ICR).
Key Findings from the OrigAMI-4 Trial
The data, presented at the world’s largest cancer conference, the 2026 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, comes from the OrigAMI-4 trial.
Conducted across 11 countries, the study enrolled 102 patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), the sixth most common cancer worldwide.
- Overall Response Rate (ORR): 43 out of 102 patients (42%) saw their tumors shrink or disappear.
- Tumor Elimination: In 15 patients, doctors found that the treatment had completely eradicated their tumors.
- Speed of Response: The median time to first response was remarkably quick at just 6.4 weeks.
- Durability: For those who responded, the benefit lasted a median of 7.2 months.
- Broader Potential: Researchers noted similar positive results in a separate group of lung cancer patients.
How the ‘Smart Jab’ Works
Amivantamab is a bispecific antibody, often described as a “smart jab,” that attacks cancer cells through a three-pronged mechanism.
- Blocks EGFR: It latches onto the Epidermal Growth Factor Receptor (EGFR), a protein that acts as an “on switch” for tumor growth.
- Blocks MET: At the same time, it blocks the MET pathway, a frequent escape route that cancer cells use to resist therapy.
- Recruits the Immune System: The antibody’s presence on the cancer cell also flags it for destruction by the body’s own immune cells.
This combination is meant to overcome resistance that usually develops against single-target therapies.
Patient Story: Carl Walsh
One of the first patients to benefit was Carl Walsh, a 56-year-old from Birmingham, UK. Diagnosed with tongue cancer in 2024, he went through grueling chemotherapy and immunotherapy that ultimately failed.
“I was struggling to speak properly and eating was difficult because of the swelling and pain,” Walsh said. He joined the trial in July 2025.
The change was dramatic. “After just two cycles of treatment, my diet started to return to normal… My speech is fully back to normal.”
He now enjoys eating steak again, a simple pleasure that had been impossible during his earlier treatments.
A New Standard of Care?
For decades, the standard of care for recurrent or metastatic head and neck cancer has been limited. Once a patient fails first-line therapies, response rates to later treatments often drop to just 15–20%.
The 42–56% response rate seen with amivantamab marks a major step forward. The US Food and Drug Administration (FDA) recognized this potential by granting the drug Breakthrough Therapy Designation for this specific use in February 2026, a status designed to speed up the development of promising drugs.
Dr. Ranee Mehra, director of Head and Neck Medical Oncology at the University of Maryland, noted that 82% of trial participants experienced some degree of tumor shrinkage. “For patients to have better quality of life, they need significant tumor shrinkage. This can translate into better symptom control, less pain, [and] improved ability to maintain nutrition,” she told CURE.
Quality of Life Improvements
Unlike many cancer therapies that require lengthy IV infusions in a hospital, this new treatment is given as a subcutaneous injection (under the skin) in just a few minutes. This makes it possible to administer in a regular outpatient clinic.
While side effects occurred—including stomatitis (23%), rash (20%), and hypoalbuminemia (31%)—they were generally manageable, with fewer than 10% of patients discontinuing treatment because of adverse events.
What Happens Next?
While the results are historic for a group with such a poor prognosis (median overall survival reached 12.5 months where few options existed before), researchers caution that this is not yet a cure for everyone.
The next phase, the OrigAMI-5 trial (NCT07276399), is already underway. This Phase 3 study will test amivantamab plus standard chemotherapy against the current standard of care in a much larger group of 500 patients.
For now, the medical community is celebrating a rare, clear win. “This treatment has the potential to benefit many thousands of patients each year,” concluded Professor Harrington.
This article was written on May 31, 2026, based on data presented at the ASCO conference and subsequent publications.
by AARON HARRIS