Barbara Burtness, MD, discusses the effectiveness of immunotherapy in patients with platinum-refractory head and neck cancers.
Barbara Burtness, MD, professor of Medicine, Medical Oncology, Disease Aligned Research Team Leader, Head and Neck Cancers Program, co-director of the Developmental Therapeutics Research Program, Yale Cancer Center, discusses the effectiveness of immunotherapy in patients with platinum-refractory head and neck cancers.
The first step in establishing that immunotherapy is active in head and neck cancers was to show that there are targets for the immune system, says Burtness. Evidence suggests that the targets in head and neck cancer can be infiltrated by neoantigenic tumor-associated immune cells with the mutational load seen in human papillomavirus (HPV)—negative and -positive cancers. Data from early trials suggest that the higher the mutational load, the more likely patients will experience a partial or complete response, according to Burtness.
The phase Ib KEYNOTE-012 trial was the first to examine the use of the PD-1 inhibitor pembrolizumab (Keytruda) in patients with head and neck cancer. Results showed that the agent was active in patients with platinum-refractory disease, regardless of HPV status, says Burtness. The phase II KEYNOTE-055 trial followed; results showed that pembrolizumab was also active in patients with cetuximab-refractory disease, according to Burtness.
The phase III CheckMate-141 trial compared the use of the PD-1 inhibitor nivolumab (Opdivo) versus investigator’s choice of standard-of-care chemotherapy in patients with platinum-refractory disease. Results showed the median overall survival was 7.5 months in the nivolumab arm versus 5.1 months in the chemotherapy arm.
These trials present positive evidence supporting the use of PD-1 agents in head and neck cancer, according to Burtness, with modest response rates ranging from 16% to 20%. These data led to FDA approvals in platinum-refractory head and neck cancer, concludes Burtness.