US drug major Eli Lilly (NYSE: LLY) says the Phase III REACH trial of Cyramza (ramucirumab) in patients with hepatocellular carcinoma (or liver cancer) did not meet its primary endpoint; overall survival favored the Cyramza arm but was not statistically significant. Lilly’s shares dipped 1.2% in pre-market trading.
However, encouraging single-agent Cyramza activity was observed, with meaningful improvements in key secondary endpoints of progression-free survival, overall response rate and time to progression, the company noted.
The global, randomized, double-blind REACH trial compared Cyramza plus best supportive care to placebo plus best supportive care as a second-line treatment in patients with hepatocellular carcinoma (HCC) after being treated with sorafenib in the first-line setting. The top-line safety data were consistent with what was seen in previous single-agent Cyramza studies. The most common (>5% incidence) grade >/=3 adverse events occurring at a higher rate on the Cyramza arm compared to the control arm were hypertension and asthenia (fatigue).
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