The trial, conducted in part by the Institute of Cancer Research, London, and the Royal Marsden NHS Foundation Trust, investigated the addition of the synthetic antibody amivantamab to the existing combination of pembrolizumab and chemotherapy. Amivantamab targets two proteins, EGFR and MET, to halt tumour growth and mobilise the immune system.
Earlier phases of the trial had shown tumour shrinkage in 42 per cent of patients treated with amivantamab alone and 56 per cent with amivantamab plus pembrolizumab. The latest phase, which included 29 patients, tested all three drugs together. Among the 22 patients with head and neck cancers not linked to high-risk human papillomavirus (HPV), tumours shrank in 77 per cent, compared with 36 per cent for the current first-line treatment of pembrolizumab plus chemotherapy. Three patients showed no detectable cancer. The disease stabilised in four patients and progressed in one. At the time of analysis, 11 of the 17 patients who responded continued to see their tumours shrink or remain stable.
Holly Stubbs, a 29-year-old mother of three from County Durham, was diagnosed with incurable tongue cancer after her disease returned following surgery and radiotherapy. She began the triple-combination therapy in July. “Scans have already shown a 60 per cent reduction in my cancer and the intense pain I was previously experiencing disappeared within the first few weeks of starting treatment,” Stubbs said. “When I thought there was nothing else that could be done, the trial gave me hope.”
Professor Kristian Helin, chief executive of the Institute of Cancer Research, London, said the results suggest that treating the biology of the tumour, rather than the disease as a single entity, can improve outcomes. “In this case, that means hitting the EGFR and MET signals that HPV-unrelated tumours rely on, while also helping the immune system attack the cancer,” he said.
Professor Kevin Harrington, professor of biological cancer therapies at the Institute of Cancer Research, London, and consultant clinical oncologist at the Royal Marsden NHS Foundation Trust, noted that the strongest activity was observed in patients with HPV-unrelated disease, “who typically have poorer outcomes and fewer effective treatment options”. He added that the decision to move to a Phase III trial reflects confidence in the results and provides an important opportunity to determine whether the regimen can improve outcomes for patients.
The researchers cautioned that the numbers remain small and that the Phase III trial will be the real test, but described the approach as a rational, biology-driven drug combination with the potential to transform outcomes for patients with hard-to-treat cancers.
