Lilly Announces Chinese Subgroup Results from Phase III REACH-2 Trial of Ramucirumab as Second-Line Therapy in Advanced Hepatocellular Carcinoma

Source: PharmCube Info

On September 25, Eli Lilly presented data from the Chinese subpopulation of the REACH-2 study at the CSCO Congress.

The REACH-2 study was an international, multicenter, randomized, double-blind, placebo-controlled Phase III trial that enrolled 292 patients with advanced hepatocellular carcinoma (HCC) who experienced disease progression following sorafenib therapy and had an alpha-fetoprotein (AFP) level ≥400 ng/mL. Patients were randomized to receive ramucirumab monotherapy or placebo.

At the 2018 ASCO Annual Meeting, Eli Lilly announced that the study yielded positive results, demonstrating a significant overall survival (OS) benefit. The data presented at this CSCO Annual Meeting are from the Chinese cohort, which enrolled a total of 104 patients with advanced hepatocellular carcinoma who experienced disease progression during or after sorafenib treatment, or were intolerant to sorafenib (BCLC stage B/C, baseline AFP ≥400 ng/mL, ECOG PS 0 or 1).

The ramucirumab and placebo groups comprised 70 and 34 patients, respectively. Results showed that the median OS for the ramucirumab group (n=70) and the placebo group (n=34) was 9.07 and 6.18 months (HR=0.854), respectively, and the median PFS was 2.76 and 1.45 months (HR=0.488). The ORR was 4.3% and 0.0%, and the DCR was 50.0% and 32.4%, respectively. These findings demonstrate survival benefits consistent with the global pivotal registration trial REACH-2. The treatment was generally well tolerated in Chinese patients, consistent with the known safety profile of ramucirumab, and no new safety signals were observed.

Ramucirumab is a fully human IgG1 monoclonal antibody that specifically binds to VEGFR-2, potently blocking the binding of VEGF-A to VEGFR-2 and also inhibiting the binding of VEGF-C and VEGF-D to VEGFR-2. The vascular endothelial growth factor (VEGF) pathway is a critical signaling pathway involved in tumor angiogenesis and serves as a major pathway in the targeted therapy of hepatocellular carcinoma.