Nivolumab More than Doubles One-Year Overall Survival in Head/Neck Cancer

Treatment with nivolumab reduced the risk of death and improved one-year overall survival (OS) compared with investigator’s choice of therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma, according to clinical trial findings presented at the 2016 American Association for Cancer Research Annual Meeting (April 16-20; New Orleans, LA).

In the trial, which was led by Maura Gillison, MD, PhD, Ohio State University (Columbus, OH), 361 patients with cancer of the oral cavity, pharynx, or larynx were randomized to received nivolumab (n=240) or investigator’s choice of cetuximab, methotrexate, or docetaxel (n=121). Patients were predominately male (83%) with a median age of 60 years. Most patients had received at least 2 prior systemic therapies. 


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The trial’s primary endpoint was overall survival, with secondary outcome measures focused on response rates and progression-free survival (PFS). Results were originally not scheduled to be released until October 2016, but an independent monitoring panel determined that nivolumab met primary endpoint goals early compared with investigator’s choice of therapy.

Median OS with nivolumab was 7.5 months compared with 5.1 months with investigator’s choice of therapy. Additionally, 1-year OS rate was 36%, more than double that observed in the investigator’s-choice group (16.6%).

Patients with PD-L1 expression ≥ 1% benefited the most from treatment with nivolumab, which is an anti-PD-1 agent; OS in this group was 8.7 months versus 4.6 months in the control arm. For patients with PD-1 expression < 1%, median OS was actually slightly shorter than in the control arm (5.7 months vs 5.8 months).

The rate of grade 3 or 4 adverse events associated with nivolumab use was also significantly lower than what was found in those treated with investigator’s choice therapy (13.1% vs 35.1%).

“Nivolumab is the first agent to demonstrate a significant improvement in survival in patients with head and neck cancer that has progressed after platinum-based chemotherapy that was demonstrated in this randomized, phase III comparative trial,” said Dr Gillison. “This fulfills an incredible unmet need in the clinic.”

She continued that a number of studies are being planned to further explore how nivolumab might benefit a larger demographic of patients with head and neck cancer.