The U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who have disease progression on or after platinum-based therapy.1

Approval was based on findings from the international, open-label, phase 3 CheckMate 141 trial ( Identifier: NCT02105636), which demonstrated a statistically significant 30% reduction in the risk of death with nivolumab compared with investigator’s choice of chemotherapy (hazard ratio, 0.7; 95% CI, 0.52-0.92; P = .0101). Estimated median overall survival was 7.5 months (95% CI, 5.5-9.1) in the nivolumab arm vs 5.1 months (95% CI, 4-6.0) in the chemotherapy arm.

There was no significant difference in progression-free survival (hazard ratio, 0.89; 95% CI, 0.70-1.13) or overall response rate between the 2 treatment arms. A total of 13.3% (95% CI, 9.3-18.3) of nivolumab-treated patients achieved an overall response compared with 5.8% (95% CI, 2.4-11.6) in the chemotherapy group.

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The study enrolled 361 patients with HSNCC who had disease progression on or within 6 months of receiving platinum-based therapy. Participants were randomly assigned 2:1 to receive intravenous nivolumab every 2 weeks or investigator’s choice of chemotherapy (cetuximab, methotrexate, or docetaxel) until disease progression or unacceptable toxicity.

Nearly half (49%) of patients receiving nivolumab had serious adverse reactions; the most common adverse events in the nivolumab arm were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis.

Cough, dyspnea, increased alkaline phosphatase, increased amylase, hypercalcemia, hyperkalemia, and increased thyroid-stimulating hormone occurred more often in the nivolumab arm than the chemotherapy arm.

The recommended dose and frequency of nivolumab for HNSCC is 3 mg/kg intravenously every 2 weeks.

RELATED: FDA Places Partial Clinical Hold on Enrolment of Durvalumab Trials in HNSCC

Nivolumab is also indicated for advanced melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and classical Hodgkin lymphoma. Clinicians should be advised that nivolumab is given at different doses with respect to indication.


  1. Nivolumab for SCCHN. U.S. Food and Drug Administration Approved Drugs website. Updated November 10, 2016. Accessed November 10, 2016.