A new immunotherapy doubles overall survival and improves quality of life with fewer side effects in previously treated metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN), according to a large, randomized international trial.
The findings are from the international CheckMate-141 clinical trial, and were presented in June at the American Society of Clinical Oncology annual meeting.
“These exciting results indicate that there is a new standard of care option for a population of head and neck cancer patients with no other treatment options,” said Robert Ferris, MD, PhD, chief of the division of head and neck surgery and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, and the trial’s international co-chair.
The new drug, nivolumab, an immunotherapeutic, currently is approved to treat some types of cancers, including melanoma and lung cancer.
The phase III study enrolled 361 patients with recurrent or metastatic SCCHN who had not responded to platinum-based chemotherapy. Patients were randomized to receive either nivolumab or a single type of standard chemotherapy until tumor progression was observed. The median overall survival (OS) with nivolumab was 7.5 months compared with 5.1 months with investigator’s choice (HR, 0.70; 95% CI, 0.51-0.96; P = .0101). The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator’s choice. After 12 months, 36% of the nivolumab group was alive, compared with 17% of the standard chemotherapy group.
Additionally, nivolumab appeared to be most successful in patients with tumors positive for human papillomavirus (HPV).
The trial was funded by the drug manufacturer, Bristol-Myers Squibb, which is now seeking FDA approval for the use of nivolumab in head and neck carcinoma.