A Novel Class of Therapeutic Biologics Shows Promise for HPV-Related Head and Neck Cancer
Head and neck cancers make up nearly 4% of all cancers in the United States, according to the National Cancer Institute. These cancers, which are more commonly diagnosed in men, are often linked to the human papillomavirus (HPV), especially HPV type 16. The majority of HPV related head and neck cancers start in the squamous cells that line the back of the throat including the tonsils, base of the tongue and soft palate.
The disease can be treated with surgery, radiation therapy, chemotherapy, targeted therapy or immunotherapy. If detected early, many of the HPV related head and neck cancer can be cured. However, if the cancer recurs after the initial treatment or the cancer spreads to parts of the body outside of the head and neck region, it is very difficult to cure.
In this challenging setting, what are the treatment options and prognosis for those whose cancer has spread?
“Patients with recurrent metastatic head and neck cancer face a poor prognosis,” explained Christine Chung, MD, chair of the Head and Neck-Endocrine Oncology Department at Moffitt Cancer Center. “Currently, the standard of care involves a medicine called pembrolizumab, but this approach alone is often not enough.”
In an effort to improve outcomes for patients with recurrent metastatic head and neck cancer, Chung and her team conducted a study to explore a new treatment approach for HPV 16-positive cases. The study focused on a novel therapy, CUE-101, which is designed to selectively engage and modulate HPV 16-specific T cells in the immune system, which can attack HPV 16-related cancer cells. The researchers tested CUE-101 both as a standalone treatment and in combination with pembrolizumab, an established immunotherapy, to assess its potential for enhancing immune response and improving patient outcomes.
The study was recently presented at the Society for Immunotherapy of Cancer annual meeting in Houston.
During #SITC24, Christine Chung, MD (@CHChungMD) presents that CUE-101 shows promising efficacy and safety for HPV16+ head and neck cancer, achieving a 46% objective response rate and a 12-month survival rate of 91.3% in combination with pembrolizumab, offering hope for better… pic.twitter.com/Q450wzBZVB
— Moffitt Cancer Center (@MoffittNews) November 8, 2024
The researchers enrolled 80 patients on the trial and followed them to assess efficacy and toxicities. They treated 49 patients with CUE-101. This was given to patients whose cancer didn’t respond to at least one previous chemotherapy or immunotherapy treatment. The researchers first tested different dosages to determine the safest and most effective dose of CUE101. They found that the best dose was 4 milligrams per kilogram, given every three weeks.
Based on this initial data, they gave a combination of CUE-101 4 milligrams per kilogram and pembrolizumab to the second cohort of patients who was not previously treated for their recurrent metastatic head and neck cancer.
“Oftentimes when you combine drugs, you can potentially increase toxicities, but in this case, they did not increase the toxicity significantly,” Chung said. “In patients who responded to the monotherapy or combination therapy, the response was durable.”
The study results revealed significant improvements, showing that CUE-101, whether used alone or with pembrolizumab, was safe and offered clinical benefits for patients with HPV 16-positive head and neck cancer. This treatment demonstrated strong potential for controlling the disease and extending patient survival.
Chung says the next steps are to conduct a larger validation study with more patients and move forward to a randomized phase 3 clinical trial.
