Drugs Xagena
The U. S. Food and Drug Administration ( FDA ) has approved Opdivo ( Nivolumab ), 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 squamous cell carcinoma of the head and neck 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 2 weeks intravenously ( IV ) ( n=240 ) or investigator’s choice ( 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 has demonstrated a statistically significant and clinically meaningful improvement in overall survival ( OS ) associated with the Nivolumab arm ( hazard ratio, HR=0.7 [ 95% CI: 0.52, 0.92 ]; p=0.0101, stratified log rank test ).
Estimated median overall survival was 7.5 months ( 95% CI=5.5, 9.1 ) in the Nivolumab arm and 5.1 months ( 95% CI=4, 6.0 ) for standard therapy.
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 standard therapy were cough and dyspnea.
The most common laboratory abnormalities occurring in 10% or more Nivolumab-treated patients and at a higher incidence than standard therapy were increased alkaline phosphatase, increased amylase, hypercalcemia, hyperkalemia, and increased TSH ( thyroid-stimulating hormone ). ( Xagena )
Source: FDA, 2016
XagenaMedicine_2016
