Liver Cancer Treatment Ramucirumab (Cyramza) Fails to Meet Primary Endpoint in Pivotal Trial
Overall survival similar between active treatment and placebo
The pivotal REACH study of ramucirumab (Cyramaz, Eli Lilly) in patients with hepatocellular carcinoma (HCC) did not meet its primary endpoint (overall survival); this endpoint favored the ramucirumab arm but was not statistically significant.
Improvements were observed, however, in key secondary endpoints of progression-free survival (PFS), the overall response rate (ORR), and time to progression.
REACH was a phase III, randomized, double-blind trial of ramucirumab plus best supportive care compared with placebo and best supportive care as second-line treatment in patients with HCC who had been treated with sorafenib (Nexavar, Bayer HealthCare) in the first-line setting. Initiated in 2010, the study enrolled 565 patients in 27 countries. The primary analyses focused on patients with Child-Pugh scores of less than 7 (Child-Pugh class A). The primary efficacy endpoint was overall survival, and key secondary endpoints included PFS, ORR, time to progression, and safety.
Cyranza (ramucirumab) as a single agent is approved in the U.S. for the treatment of patients with advanced gastric cancer or gastroesophageal-junction adenocarcinoma who have progressed after prior fluoropyrimidine- or platinum-containing chemotherapy. The medication was granted an “orphan drug” designation by the FDA for the treatment of HCC.
Ramucirumab is a vascular endothelial growth factor (VEGF) receptor 2 antagonist that specifically blocks the activation of this receptor and its ligands (VEGF-A, -C, and -D). The drug is being investigated in clinical trials as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types.
The labeling for Cytanza (ramucirumab) includes a boxed warning regarding an increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.
Source: Eli Lilly; June 11, 2014.