Early data from a multinational cancer trial have doctors taking notice, as a triple-action injection called amivantamab appears to shrink - and in some cases completely eliminate - tumors in patients whose cancers had stopped responding to standard treatments. Clinicians reported dramatic tumor reductions within weeks, and several patients said symptoms such as pain and difficulty speaking eased as the growths pulled back. The findings were slated for presentation at the American Society of Clinical Oncology annual meeting in Chicago on Sunday.
In the head-and-neck cohort of the OrigAMI-4 study, 102 patients with recurrent or metastatic head and neck squamous cell carcinoma took part after their disease progressed on platinum chemotherapy and PD-1/PD-L1 inhibitors. In that group, tumors shrank or disappeared in 43 patients, with 28 showing substantial shrinkage and 15 experiencing complete disappearance. Patients lived a median of 12.5 months after starting treatment, according to The Guardian.
Amivantamab is a bispecific monoclonal antibody developed by Johnson & Johnson that blocks both EGFR and MET signaling and also helps recruit immune cells to attack tumors. The company and study investigators say the subcutaneous formulation can be delivered as a short injection instead of a lengthy IV infusion, and the drug is being tested across multiple tumor types in dozens of trials worldwide, according to Johnson & Johnson.
The subcutaneous combination of amivantamab and hyaluronidase (marketed as Rybrevant Faspro) received U.S. regulatory approval for subcutaneous injection on December 17, 2025, a move advocates say makes delivery quicker and easier for outpatient clinics. That approval is listed on the U.S. Food and Drug Administration's oncology approvals page at the FDA.
Patients' improvements and clinician reaction
One participant, 56-year-old Carl Walsh, was diagnosed with tongue cancer in May 2024 and joined the study in July 2025. He told reporters that after starting treatment his speech and ability to eat improved as the tumor responded. Investigators, including Professor Kevin Harrington of the Institute of Cancer Research and the Royal Marsden, described the responses as "unprecedentedly strong" in patients whose disease had resisted chemotherapy and immunotherapy, according to The Independent.
What researchers caution
Researchers are quick to point out that these are early, single-arm results, and only randomized trials can show whether the responses translate into durable survival benefits. Preliminary reporting has cited a 45% overall response rate and a 75% clinical-benefit rate in the head-and-neck cohort, with a median time to response of about six weeks and a median duration of response of roughly 7.2 months, according to analysis by the Cleveland Clinic. The safety profile included skin reactions, stomatitis and other toxicities described as manageable, and investigators say long-term follow up will be crucial.
Johnson & Johnson says it will present pivotal OrigAMI-4 data at the ASCO meeting and has flagged further development, including a planned Phase 3 study building on these findings. The company highlighted the ASCO program and its abstracts in a press release describing its presentations at the conference, according to Johnson & Johnson.
For now, researchers are preaching cautious optimism. The responses seen so far are striking, but they say larger randomized trials and peer-reviewed publications are needed before any change in standard care. Investigators at the Institute of Cancer Research describe the results as an important step forward while stressing the need for continued follow-up and broader testing, according to The Guardian.
