Researchers Explore New Treatment for Aggressive Head and Neck Cancer
Hope is on the horizon for patients with advanced head and neck cancer as researchers explore a new treatment strategy.
Results presented at the 2025 American Society of Clinical Oncology Annual Meeting from an ongoing clinical trial show that pairing two drugs, ficerafusp alfa and pembrolizumab, may significantly improve outcomes for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), particularly those who test negative for the human papillomavirus (HPV).
Christine Chung, MD
“HPV-negative HNSCC is known to be more aggressive and harder to treat than HPV-positive forms. These cancers often come back after initial treatment and are more resistant to standard therapies,” said Christine Chung, MD, the study’s lead investigator and chair of the Head and Neck-Endocrine Oncology Department at Moffitt Cancer Center.
The study, which enrolled 30 adult patients with incurable head and neck cancer, tested the combination of ficerafusp alfa, a drug designed to block two cancer-driving pathways, with pembrolizumab, an existing immunotherapy drug approved by the U.S Food and Drug Administration.
Patients received ficerafusp weekly and pembrolizumab every three weeks. Only HPV-negative patients were enrolled.
After two years of follow-up, the results have been encouraging. Of the 28 patients whose cancer could be evaluated, 54% responded to treatment, and 21% achieved a complete response, meaning all signs of cancer temporarily disappeared.
Even more promising, many of the patients who responded to the treatment stayed in remission for long periods.
Among HPV-negative patients who responded, 79% had a response that lasted at least six months or longer and 65% maintained that response for at least a year. The average time patients lived without their disease getting worse was about 9.9 months. After 2 years of treatment, more than 46% of HPV-negative patients were still alive, with a median overall survival of 21.3 months.
While pembrolizumab is already used to treat this type of cancer, ficerafusp alfa brings something new to the table.
It targets two pathways that help cancer grow and resist treatment. Combining the two drugs may help the immune system fight cancer more effectively.
“While these early results are encouraging, it’s important to note that this was a small study without a comparison group,” Chung said. “That’s why a larger, more definitive phase 2/3 trial is already underway to evaluate the treatment in a broader group of patients and under more rigorous conditions.”
If the results hold, this drug combination could represent a major breakthrough for patients with limited options.
“Patients with incurable cancers may have a promising new treatment option,” Chung added.
The next phase of the trial will determine whether the new combination should become a new standard of care for patients with HPV-negative head and neck cancer.
