Positive results for Phase III REACH-2 study of Cyramza a treatment for liver cancer.- Eli Lilly.

Eli Lilly and Company announced top-line results from its Phase III 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 tumor types in Phase III 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 Grade greater than 3 adverse events occurring at a rate of five percent or greater in the Cyramza arm were hypertension and hyponatremia (low sodium). The efficacy and safety results will be submitted for presentation at a future medical meeting.

REACH-2 is the first positive Phase III 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), defined as an AFP of greater than 400 ng/mL. 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. While there have been some recent advances in treating HCC, there remains a very high unmet need for patients in this treatment setting. 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. This REACH-2 outcome also builds upon Lilly's efforts and commitment to providing treatment options for people living with HCC and gastrointestinal cancers. In addition to the Phase III REACH and REACH-2 trials, Lilly is evaluating Cyramza with an immuno-oncology agent in HCC in a Phase 1b study cohort, and is conducting various studies of Cyramza in other gastrointestinal cancers, including gastric, colorectal and biliary tract. Lilly intends to initiate regulatory submissions in mid-2018.