Liver cancer drug CYRAMZA® succeeds in Phase 3 trials

Hannah Alderton 04 April 2018

Eli Lilly and Company have announced top-line results from its Phase 3 REACH-2 study of CYRAMZA® (ramucirumab) as a single agent in the second-line treatment of people with hepatocellular carcinoma (HCC), also known as liver cancer. The trial met its primary endpoint of overall survival (OS) as well as the secondary endpoint of progression-free survival (PFS). CYRAMZA has now demonstrated a survival benefit in four aggressive, difficult-to-treat tumour types in Phase 3 studies, including as a single agent in both gastric cancer and HCC.

The safety profile observed in the REACH-2 study was consistent with what has been previously observed for single-agent CYRAMZA. The only adverse events occurring at a rate of five percent or greater in the CYRAMZA arm were hypertension and hyponatremia (low sodium).

REACH-2 is the first positive Phase 3 HCC trial in a biomarker-selected patient population. The REACH-2 study evaluated the benefit of CYRAMZA treatment in HCC patients who were intolerant to, or had disease progression while on or following treatment with, sorafenib and had a high alpha-fetoprotein (AFP-High). Approximately half of all advanced HCC patients are AFP-High and these patients are among those with the poorest prognosis relative to the general HCC patient population.

With this positive outcome, the REACH-2 study has confirmed the hypothesis generated by the REACH trial results, which showed that a pre-specified subgroup of advanced HCC patients who were AFP-High derived a survival benefit from treatment with CYRAMZA following first-line treatment with sorafenib.

Levi Garraway, Lilly Oncology said, "Advanced liver cancer is an aggressive disease that has a poor prognosis – and for those that have elevated AFP levels, the prognosis is even more dismal. The expected survival of these patients is only a few months following first-line treatment if they don't go onto second-line therapy.”

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