Dr. Llovet on REACH Trials With Ramucirumab in HCC

Josep M. Llovet, MD, PhD, founder and director of the Liver Cancer Program, full professor of medicine, Icahn School of Medicine, Mount Sinai Hospital, discusses the REACH and REACH-2 trials, which examined ramucirumab (Cyramza) versus placebo in sorafenib (Nexavar)-intolerant patients with hepatocellular carcinoma (HCC) and elevated baseline alpha fetoprotein (AFP).

The REACH trial compared ramucirumab with placebo in all patients and the results were negative. However, in a subgroup analysis of patients with high AFP, or patients with aggressive tumors, ramucirumab showed activity, according to Llovet. As a result, the company designed a second trial called REACH-2.

REACH-2 suggested that ramucirumab has a significantly better survival compared with placebo and had positive results. A pooled analysis of both the REACH and REACH-2 studies included patients who progressed on sorafenib and those who were intolerant to the agent. The median overall survival (OS) for ramucirumab versus placebo in those who progressed on sorafenib was 8 months versus 4.7 months. For patients who were sorafenib-intolerant, the OS was 10.2 months versus 6.7 months for ramucirumab and placebo, respectively.

In May 2019, the FDA approved ramucirumab monotherapy for patients with HCC who have an AFP of ≥400 ng/ML and have been previously treated with sorafenib, based on the REACH-2 data.