Nivolumab New Care Option for Head and Neck Cancer

Immunotherapy treatment with nivolumab significantly improved survival among patients with recurrent or metastatic head and neck squamous cell carcinoma (SCCHN), according to interim analysis results of the phase III CheckMate-141 study presented at the 2016 American Association for Cancer Research (AACR) Annual Meeting, held April 16–20 in New Orleans.

Patients in the study assigned to nivolumab had a 30% reduction in the risk for death, and in those patients who were PD-L1 positive and p16-positive-a marker for human papillomavirus positivity-the risk for death was reduced by approximately half.

“Nivolumab is the first agent to demonstrate a significant improvement in overall survival in patients with SCCHN who progress after platinum-based therapy in a randomized, phase III comparative trial and fulfills an incredible unmet need in the clinic,” said Maura L. Gillison, MD, PhD, a professor in the department of internal medicine at the Ohio State University Comprehensive Cancer Center in Columbus, Ohio. “Nivolumab, therefore, represents a new standard of care option for patients with recurrent or metastatic SCCHN after platinum-based therapy.”

According to Gillison, about 50% of patients treated for SCCHN will have their disease recur within 3 to 5 years. SCCHN that recurs within 6 months is a particularly devastating disease with an average survival of less than 6 months, Gillison said.

The trial included 361 patients with SCCHN who had progressed within 6 months of receiving treatment with platinum-based chemotherapy. The patients were randomly assigned 2:1 to 3 mg/kg nivolumab every 2 weeks or weekly investigator’s choice consisting of single-agent chemotherapy with methotrexate, docetaxel, or cetuximab.

At the interim analysis, 55.4% of patients assigned nivolumab had died and 70.2% of patients assigned investigators choice had died. Patients assigned nivolumab had a 30% reduction in the risk for death compared with investigator’s choice (hazard ratio [HR], 0.70 [97.73% CI, 0.51-0.96]; P = .010). The median overall survival was more than 2 months longer for patients assigned the immunotherapy (7.5 vs 5.1 months; 95% CI, 4.0–6.0).

Although nivolumab demonstrated a survival benefit in the overall study population regardless of PD-L1 expression or p16 status, the researchers also evaluated overall survival by these two factors.

Compared with investigator’s choice, nivolumab resulted in a 45% reduction in the risk for death (HR, 0.55) in patients with PD-L1 of 1% or greater and an 11% reduction in patients with PD-L1 less than 1%. Similarly, nivolumab was associated with a 44% reduction in the risk for death in patients who were p16-positive and a 27% reduction in the risk for death in patients who were p16-negative.

According to Gillison, the frequency, type, and grade of toxicity was similar to what was seen in other clinical trial populations. More than half of patients (58.9%) experienced treatment-related adverse events of any grade while on nivolumab and 13.1% had grade 3/4 events. However, in patients assigned to investigator’s choice chemotherapy, 77.5% experienced treatment-related adverse events and 35.1% had a grade 3/4 event.