A Phase 3 clinical trial, REACH-2, assessing Eli Lilly's (NYSE:LLY) CYRAMZA (ramucirumab) as monotherapy for the second-line treatment of certain patients with hepatocellular carcinoma (HCC) met the primary endpoint of overall survival (OS) and the secondary endpoint of progression-free survival (PFS).
The specific patients evaluated where those with HCC who progressed on or were intolerant of sorafenib (Bayer's NEXAVAR) and had high levels of a biomarker called alpha-fetoprotein (AFP-High), a profile with a poor prognosis.
The safety profile was consistent with earlier studies. The only grade 3 (serious) or greater adverse events occurring at a rate of at least 5% were hypertension and hyponatremia (low blood sodium).
The company will initiate regulatory filings this summer.
CYRAMZA, a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist, is currently approved in the U.S. to treat gastric cancer or gastroesophageal junction adenocarcinoma, non-small lung cancer and colorectal cancer.
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