Eli Lilly reported positive results from its phase 3 REACH-2 study with ramucirumab (Cyramza), according to a company press release. Ramucirumab is being studied as a single-agent second-line treatment for patients with hepatocellular carcinoma (HCC), also known as liver cancer.
REACH-2 is the first positive phase 3 HCC trial in a biomarker-selected population.
Previously-completed phase 3 trials of ramucirumab have demonstrated survival benefit in advanced gastric, non-small cell lung and colorectal cancers.
Approximately half of all advanced HCC patients have a high alpha-fetoprotein (AFP-High), which is a marker of poor prognosis relative to the general HCC patient population, according to Eli Lilly. Advanced HCC has few approved systemic treatments and prognosis is typically very poor, indicating an unmet need for patients in this treatment setting.
“The expected survival rate of these patients is only a few months following first-line treatment if they don’t go to second-line therapy,” Levi Garraway, MD, PhD, senior vice president of global development and medical affairs at Lilly Oncology, said in the press release. “For this reason, Lilly is encouraged by the results of REACH-2 and the potential for Cyramza to benefit patients in this setting.”
In the study, investigators evaluated the benefit of treatment with ramucirumab in patients with HCC who were intolerant to, or had disease progression while on or following treatment with sorafenib and were AFP-High.
Investigators studied the use of ramucirumab and best supportive care (BSC) compared with a placebo and BSC in patients with HCC. The study enrolled 292 patients across 20 countries. The primary endpoint of the trial is overall survival (OS) and key secondary endpoints include progression-free survival, objective response rate, quality of life, and safety.
Although the primary endpoint of OS showed favorable results in the patients treated with ramucirumab, it was not statistically significant. However, a greater survival benefit was observed along with meaningful improvement in key secondary endpoints in a pre-specified subgroup of patients who were AFP-High.
Ramucirumab’s safety profile in the REACH-2 study remained consistent with what was previously observed for single-agent ramucirumab. Adverse effects that occurred at a rate of 5% or greater in the ramucirumab group were hypertension and hyponatremia.
Lilly Announces CYRAMZA (ramucirumab) Phase 3 REACH-2 Study in Second-Line Hepatocellular Carcinoma Patients Met Overall Survival Endpoint [news release]. Indianapolis. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lilly-announces-cyramzar-ramucirumab-phase-3-reach-2-study
. Accessed April 5, 2018.