Eli Lily has announced that Cyramza (ramucirumab) met its primary endpoint of overall survival (OS) compared to placebo when administered as a single agent in the second-line treatment of individuals with hepatocellular carcinoma (HCC).
REACH-2 was a randomized, double-blind, placebo-controlled trial that enrolled 292 patients with hepatocellular carcinoma (HCC) who were intolerant to, or had disease progression while on or following treatment with sorafenib and had a high alpha-fetoprotein (AFP-High) defined as AFP ≥400ng/mL. Approximately half of all advanced HCC patients are AFP-High.
The trial was designed based on findings from the initial REACH trial, which only found statistical significance in OS in a subgroup of patients who were AFP-High. The Company says the full REACH-2 results will be presented at a future medical meeting, but that the top-line results show that it met the primary endpoint of OS and also the secondary endpoint of progression-free survival (PFS). The safety profile was consistent with previously observed findings from single-agent Cyramza administration.
Cyramza is currently approved for treating advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma which has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy; in combination with docetaxel for metastatic non-small cell lung cancer (NSCLC) which has progressed after platinum-based chemotherapy; and with FOLFIRI as a treatment for metastatic colorectal cancer (mCRC) which has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
For more information visit ClinicalTrials.gov.