The Medical University of South Carolina (MUSC) Hollings Cancer Center, US, has enrolled the first subject in the Phase II/III FORTIFI-NH01 trial of ficerafusp alfa to treat individuals with human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC) that has recurred or metastasised.
The randomised trial aims to evaluate the bifunctional antibody in conjunction with pembrolizumab, an existing immunotherapy for HNSCC, to investigate the improvements in subject outcomes.
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Ficerafusp alfa aims at both the epidermal growth factor receptor (EGFR) and human transforming growth factor beta, which in tandem, may reduce the likelihood of cancer cells developing resistance.
The trial’s approach utilises the body’s immune system, with preclinical research suggesting that the antibody “remodels” tumour’s environment to enhance immune cell access.
The combination is administered through weekly infusions.
HNSCC’s risk factors encompass HPV infection and heavy usage of alcohol or tobacco.
Hollings’ site principal investigator Dr John Kaczmar expressed optimism about the potential of this drug combo.
According to him, the doctors observed a rise in “unexplained” HPV-negative HNSCC cases among younger women.
Dr Kaczmar said: “For patients with recurrent or metastatic head neck cancer, pembrolizumab, or Keytruda, is the standard of care, either by itself or with chemotherapy. And for some people, it is hugely beneficial.
“Clinical trials like this give us the chance to potentially augment standard immunotherapy with novel immune approaches that might expand the universe of patients who are able to achieve the profound benefit that immunotherapy can provide.”
Given that HPV-positive cancers typically respond more favourably to treatments, the trial is focused on finding a more suitable therapeutic option for those with HPV-negative HNSCC.
