On November 10, 2016, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo® injection, Bristol-Myers Squibb Company), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.
Approval was based on data from an international, multi-center, open-label, randomized trial (CheckMate 141) comparing nivolumab with investigator’s choice (IC) of chemotherapy (either cetuximab, methotrexate, or docetaxel) in patients with recurrent or metastatic SCCHN with disease progression on or within 6 months of receiving platinum-based chemotherapy.
The trial enrolled 361 patients randomized (2:1) to nivolumab 3 mg/kg every two weeks via IV (n = 240) or IC (n = 121) of either cetuximab 400 mg/m2 IV once, then 250 mg/m2 IV weekly (n = 15), methotrexate 40 mg/m2 IV weekly (n = 52), or docetaxel 30 mg/m2 IV weekly (n = 54) until disease progression or unacceptable toxicity.
The trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) associated with the nivolumab arm (hazard ratio 0.7 [95% CI: 0.52, 0.92]; p = 0.0101, stratified log rank test). Estimated median OS was 7.5 months (95% CI = 5.5, 9.1) in the nivolumab arm and 5.1 months (95% CI = 4, 6.0) for IC.
Serious adverse reactions occurred in 49% of patients receiving nivolumab. The most frequent serious adverse reactions reported in at least 2% of patients receiving nivolumab were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. The most common adverse reactions occurring in more than 10% of nivolumab-treated patients and at a higher incidence than IC were cough and dyspnea. The most common laboratory abnormalities occurring in 10% or more nivolumab-treated patients and at a higher incidence than IC were increased alkaline phosphatase, increased amylase, hypercalcemia, hyperkalemia, and increased TSH.
The recommended dose and schedule for nivolumab for SCCHN is 3 mg/kg IV every two weeks.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online, by faxing (800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (800-FDA-1088).
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