Amivantamab Injection Eradicates Tumors in Resistant Head-and-Neck Cancer Patients

An international phase II study (OrigAMI-4) administered the bispecific antibody amivantamab to 102 patients with recurrent or metastatic head-and-neck squamous cell carcinoma (HNSCC) whose disease had progressed after platinum-based chemotherapy and immunotherapy. Tumor shrinkage occurred in 43 participants (42 %); 15 of these experienced complete radiographic disappearance of measurable disease. Median overall survival after the first dose was 12.5 months, and the median time to tumor response was approximately six weeks.

Oxford Mail

Amivantamab, developed by Johnson & Johnson, simultaneously blocks epidermal growth factor receptor (EGFR) and MET signaling pathways while engaging the immune system to attack tumor cells. The drug is delivered as a sub-cutaneous injection every three weeks, contrasting with the intravenous infusions required for most anticancer biologics. It is already approved for several lung-cancer indications and is now being evaluated in roughly 60 trials across lung, colorectal, brain and gastric cancers.

The Guardian

• Prof. Kevin Harrington – Professor of Biological Cancer Therapies, Institute of Cancer Research (ICR) and consultant oncologist at The Royal Marsden NHS Foundation Trust.

The Guardian

• Prof. Kristian Helin – Chief Executive, ICR.

Oxford Mail

• ICR, London – Coordinating centre of the OrigAMI-4 trial, enrolling patients from 55 hospitals across 11 countries.

The Guardian

• Royal Marsden NHS Foundation Trust – Primary clinical site for patient enrollment and treatment administration.

The Guardian

Carl Walsh, a 56-year-old from Birmingham diagnosed with tongue cancer in May 2024, entered the trial after failure of chemotherapy and immunotherapy. He reported rapid reduction of swelling, pain relief, and restoration of normal speech and diet, allowing him to resume work and social activities.

Oxford Mail

• Enrollment: 102 patients with HNSCC (HPV-negative).

Oxford Mail

• Responses: 28 partial responses, 15 complete responses, 43 total responders.

Oxford Mail

• Survival: Median overall survival 12.5 months post-treatment.

The Guardian

• Safety: Side-effects were mild to moderate; fewer than 10 % discontinued therapy due to toxicity.

Oxford Mail

• Administration: Sub-cutaneous injection every three weeks, facilitating outpatient delivery.

Oxford Mail

ICR officials emphasized that the results represent a meaningful advance for a patient group with limited therapeutic options. They highlighted the drug’s triple-action mechanism and its potential to improve quality of life by reducing treatment-related toxicity. The institute also noted that the trial excluded HPV-positive oropharyngeal cancers, which generally respond better to standard therapies.

Oxford Mail

The exclusion of HPV-positive HNSCC limits the generalizability of the findings to all head-and-neck cancers. Additionally, the study reports median overall survival but provides limited data on long-term durability of complete responses or on progression-free survival beyond the median of six-and-a-half months.

Oxford Mail

While the trial demonstrated rapid tumor shrinkage, the sources do not quantify the magnitude of response in lung-cancer cohorts where “similar results” were observed, leaving the efficacy in other tumor types uncertain. Long-term safety beyond the reported follow-up period remains unaddressed.

The Guardian

• “This is a group of patients for whom treatment options are extremely limited, so seeing this level of benefit is very striking.” — Prof. Kevin Harrington, ICR

The Guardian

• “ Unlike many cancer treatments, amivantamab is given as a tiny jab under the skin rather than via an intravenous drip, making treatment quicker and more convenient for patients and much easier to deliver in outpatient clinics.” — ICR press release

The Guardian

• “Most side-effects of the treatment, given once every three weeks, were mild to moderate, with fewer than one in 10 patients forced to stop their treatment.” — ICR press release

The Guardian

• “Prof Kristian Helin, the chief executive of the ICR, 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.” — Prof. Kristian Helin, ICR

The Guardian

Results will be presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Ongoing studies will assess amivantamab in additional solid-tumor indications and explore combination regimens to broaden its therapeutic impact.

Oxford Mail