A new study on immunotherapy for head and neck carcinoma found that the treatment doubled the overall survival and improved quality of life, with fewer side effects in treatment of rapidly progressing forms of the cancers. According to researchers, the phase three clinical trial was stopped early to allow patients in the comparison group to receive the new drug.
The study, co-led by investigators at the University of Pittsburgh Cancer Institutes (UPCI), were presented Monday at the American Society of Clinical Oncology meeting in Chicago. Researchers studied 361 patients with recurrent or metastatic head and neck squamous cell carcinoma who did not respond to platinum-based chemotherapy. This form of the disease progresses rapidly and has an especially poor prognosis. According to the Cleveland Clinic, metastatic disease at presentation is uncommon and incurable.
Half of the patients received nivolumab, an immunotherapeutic drug. This class of drugs enables the body’s immune system to destroy cancer cells and is approved for treatment of certain cancers, including melanoma and lung.
After 12 months, 36 percent of the nivolumab group was alive, compared to 17 percent of the standard chemotherapy group, according to a news release.
The immunotherapy treatment doubled the number of patients whose tumors shrank and the number whose disease had not progressed after six months of treatment.
These benefits were achieved with just one-third the rate of serious adverse events reported in the standard chemotherapy group, researchers noted.
The drug appeared to be most successful in patients whose tumors were positive for the human papillomavirus (HPV), which is noteworthy because the fraction of head and neck cancers attributable to HPV infection has increased by 250 percent over several decades, researchers noted.
“Unfortunately, most patients in this trial still experienced a progression of their cancer, demonstrating that we still have a lot of work to do,” the trial’s international co-chair Dr. Robert Ferris, Ph.D., UPMC Endowed Professor, and chief of the Division of Head and Neck Surgery and co-leader of the Cancer Immunology Program at UPCI, said in the news release. “But, the future appears brighter than ever before because there is a new class of agents, immunotherapies, which we now know can prolong survival and improve quality of life, with few side effects, in head and neck cancer.”
The study was funded by nivolumab manufacturer, Bristol-Myers Squibb, who are now seeking approval from the Food and Drug Administration.