Now that pembrolizumab has received FDA approval for use in patients with head and neck squamous cell carcinoma, however, practitioners have an alternative to offer patients with recurrent or metastatic disease. Experts predict that nivolumab (Opdivo, Bristol-Myers Squibb), another PD-L1 checkpoint inhibitor, will be the next to receive FDA approval, based on the results coming out of the CheckMate-141 study. According to lead investigator Dr. Gillison, nivolumab reduced the risk of death by 30% compared with standard therapy. One-year survival was 36% in the nivolumab arm, versus 16.6% in the control arm. Further, the proportion of patients who survived a year on nivolumab was double that of the control arm. “This is the first agent ever to show a survival benefit in platinum-refractory head and neck cancer, in the history of treating this disease,” Dr. Gillison said. “That’s why everybody is so excited.”
Indeed, immunotherapy can now be considered the fourth modality of head and neck cancer treatment, Dr. Brizel said. “The traditional platform for treating head and neck has been a table with three legs, surgery, radiotherapy, and chemotherapy. Immunotherapy, in essence, brings a fourth leg to the table.”
Monitoring Patients on Checkpoint Inhibitors
Checkpoint inhibitors are generally well tolerated. In fact, many patients experience fewer adverse events than they did on standard chemotherapy. The most common side effects include fatigue, mild diarrhea, and skin rash or itching.