News from the FDA/CDC

Nivolumab approved to treat esophageal squamous cell carcinoma


The Food and Drug Administration has approved nivolumab (Opdivo) for use in certain patients with esophageal squamous cell carcinoma (ESCC).

The checkpoint inhibitor is now approved to treat patients with unresectable advanced, recurrent, or metastatic ESCC who previously received fluoropyrimidine- and platinum-based chemotherapy.

Researchers tested nivolumab in this population in the ATTRACTION-3 trial (NCT02569242). The trial enrolled 419 patients.

The patients were randomized to receive nivolumab at 240 mg via intravenous infusion over 30 minutes every 2 weeks (n = 210) or investigator’s choice of taxane chemotherapy (n = 209), which consisted of docetaxel (75 mg/m2 intravenously every 3 weeks) or paclitaxel (100 mg/m2 intravenously once a week for 6 weeks followed by 1 week off).

Nivolumab significantly improved overall survival but not progression-free survival. The median progression-free survival was 1.7 months in the nivolumab arm and 3.4 months in the chemotherapy arm (hazard ratio, 1.1).

The median overall survival was 10.9 months in the nivolumab arm and 8.4 months in the chemotherapy arm (hazard ratio, 0.77; P = .0189). The overall survival benefit was observed regardless of tumor programmed death–ligand 1 expression.

Response rates were similar between the treatment arms, but responses were more durable with nivolumab. The overall responses rate was 19.3% in the nivolumab arm and 21.5% in the chemotherapy arm. The median duration of response was 6.9 months and 3.9 months, respectively.

Serious adverse events were reported in 38% of patients in the nivolumab arm. Serious adverse events occurring in at least 2% of patients were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia.

Adverse events prompted 13% of patients to discontinue nivolumab and 27% to delay nivolumab treatment.

Fatal adverse events in patients on nivolumab included interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%).

The recommended dose of nivolumab for ESCC is 240 mg every 2 weeks or 480 mg every 4 weeks. For more details, see the full prescribing information.

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