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FDA approves Opdivo for recurrent or metastatic HNSCC
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The FDA approved the PD-1 inhibitor nivolumab for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based therapy.
The agency based its decision on results from CheckMate 141, a randomized, open-label, multicenter trial designed to compare nivolumab (Opdivo, Bristol-Myers Squibb) with investigator’s choice of chemotherapy in 361 patients with recurrent or metastatic HNSCC whose disease progressed on or within 6 months of platinum-based chemotherapy.
Researchers randomly assigned patients to nivolumab 3 mg/kg every 2 weeks via IV (n = 240) or investigator’s choice of chemotherapy (n = 121). Treatment continued until disease progression or unacceptable toxicity.
In the investigator’s choice group, 15 patients received cetuximab (Erbitux, Eli Lilly), administered in one 400 mg/m2 IV dose, followed by weekly doses of 250 mg/m2. Fifty-two patients received methotrexate, administered in weekly IV doses of 40 mg/m2. Fifty-four patients received docetaxel, administered in weekly IV doses of 30 mg/m2.
Results showed patients assigned nivolumab achieved significantly longer median OS (7.5 months vs. 5.1 months; HR = 0.7; 95% CI, 0.52-0.92).
Forty-nine percent of patients assigned nivolumab experienced serious adverse reactions, the most frequent of which were pneumonia, dyspnea, respiratory failure, respiratory tract infection and sepsis.
Laboratory abnormalities that occurred in at least 10% of patients assigned nivolumab included increased alkaline phosphatase, increased amylase, hypercalcemia, hyperkalemia and elevated thyroid-stimulating hormone.