ON MAY 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza) as a single agent for hepatocellular carcinoma in patients who have an alpha fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib.
APPROVAL WAS based on the REACH-2 trial, a multinational, randomized, double-blind, placebo-controlled, multicenter study in 292 patients with advanced hepatocellular carcinoma with AFP levels ≥ 400 ng/mL who had disease progression on or after sorafenib or who were intolerant to treatment with sorafenib. Patients were randomly assigned 2:1 to receive ramucirumab at 8 mg/kg plus best supportive care or placebo plus best supportive care every 2 weeks as an intravenous infusion until disease progression or unacceptable toxicity.
The trial’s primary endpoint was overall survival. The estimated median overall survival was 8.5 months (95% confidence interval [CI] = 7.0–10.6 months) for patients receiving ramucirumab and 7.3 months (95% CI = 5.4–9.1 months) for those receiving placebo (hazard ratio [HR] = 0.71; 95% CI = 0.53– 0.95; P = .020).
The most common adverse reactions observed in patients with hepatocellular carcinoma receiving single-agent ramucirumab (≥ 15% and ≥ 2% higher incidence than placebo) were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities (≥ 30% and a ≥ 2% higher incidence than placebo) were hypoalbuminemia, hyponatremia, and thrombocytopenia.
The recommended ramucirumab dose is 8 mg/kg administered intravenously every 2 weeks. ■