The phase 3 REACH-2 trial of ramucirumab met its primary endpoint of OS and its secondary endpoint of PFS for the second-line treatment of patients with hepatocellular carcinoma with high alpha-fetoprotein, according to the agent’s manufacturer.
Ramucirumab (Cyramza, Lilly) — a VEGF receptor 2 antagonist — is indicated for the second-line treatment of patients with gastric or gastroesophageal junction adenocarcinoma, as well as in combination for those with non-small cell lung cancer and metastatic colorectal cancer.
The phase 3 global, double-blind, placebo-controlled REACH-2 study included 292 patients with alpha-fetoprotein-high HCC who were intolerant to or who had disease progression following treatment with sorafenib (Nexavar, Bayer). High alpha-fetoprotein — defined as levels of at least 400 ng/mL — occurs among approximately half of patients with advanced HCC and is associated with a poor prognosis.
Researchers randomly assigned patients to ramucirumab plus best supportive care or placebo plus best supportive care.
The trial met its primary endpoint of OS and its secondary endpoint of PFS.
The results will be presented at a future medical conference.
The safety profile of ramucirumab appeared consistent with previous reports. The most common grade 3 or higher adverse events included hypertension and hyponatremia.
“Advanced liver cancer is an aggressive disease that has a poor prognosis — and for those [who] have elevated alpha-fetoprotein levels, the prognosis is even more dismal,” Levi Garraway, MD, PhD, senior vice president of global development and medical affairs at Lilly Oncology, said in a press release. “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 Cyramza to benefit patients in this setting.”