Phase III REACH-2 Study in Hepatocellular Carcinoma Meets Overall Survival Endpoint
Topline results from the phase III REACH-2 study of ramucirumab (Cyramza) as a single agent in the second-line treatment of patients with hepatocellular carcinoma (HCC) were recently announced. The trial met its primary endpoint of overall survival as well as the secondary endpoint of progression-free survival.
The safety profile observed in the REACH-2 study was consistent with what has been previously observed for single-agent ramucirumab. The only grade ≥ 3 adverse events occurring at a rate of 5% or greater in the ramucirumab arm were hypertension and hyponatremia. 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 ramucirumab treatment in patients with HCC who were intolerant to or had disease progression while on or following treatment with, sorafenib (Nexavar) and had a high alpha-fetoprotein (AFP) level (≥ 400 ng/mL). Approximately half of all advanced HCC patients have high AFP levels, 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.
Initiated in 2015, the study has enrolled 292 patients across 20 countries in North America, Asia, Europe, and Latin America. Other secondary endpoints include objective response rate, quality of life, and safety.
“Advanced liver cancer is an aggressive disease that has a poor prognosis—and for those who 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. For this reason, Lilly is encouraged by the results of REACH-2 and the potential for ramucirumab to benefit patients in this setting,” said Levi Garraway, MD, PhD, Senior Vice President, Global Development and Medical Affairs, Lilly Oncology.
With this positive outcome, the REACH-2 study has confirmed the hypothesis generated by the REACH trial results, which showed that a prespecified subgroup of advanced HCC patients who had high AFP levels derived a survival benefit from treatment with ramucirumab following first-line treatment with sorafenib.
Lilly intends to initiate regulatory submissions in mid-2018.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
