Randomized study of addition of low-dose nivolumab to triple metronomic chemotherapy for aHNSCC

The regimens approved for the treatment of advanced head and neck squamous cell carcinoma (aHNSCC) are accessible to only 1% to 3% of patients in low- and middle-income countries because of their cost. A phase 3 study at Tata Memorial Hospital (Mumbai, India) evaluated addition of low-dose nivolumab to triple metronomic chemotherapy (TMC) for aHNSCC. One-year overall survival rate was 16.3% with TMC versus 43.4% with TMC plus low-dose nivolumab (HR 0.545; p=0.0036), with median overall survival 6.7 months versus 10.1 months (p=0.0052). The rate of grade 3 or higher adverse events was 50% versus 46.1%. The authors conclude that addition of low-dose nivolumab to TMC was associated improved OS and may be an alternative standard of care for patients who cannot access full-dose checkpoint inhibitors.