OS in the LIVERATION trial of namodenoson in advanced HCC appeared longer than anticipated, prompting consideration of an earlier interim analysis.
Blinded overall survival (OS) outcomes that were observed across the entire patient population in the ongoing phase 3 LIVERATION trial (NCT05201404) of namodenoson in patients with advanced hepatocellular carcinoma (HCC) appeared longer than originally anticipated based on the assumptions that were part of the study design.¹
The observed OS outcomes reflect the pooled, blinded study population and include patients who received both namodenoson and placebo; accordingly, conclusions about treatment efficacy or differences between the study arms cannot be drawn from the data at this time, according to a news release. Can-Fite BioPharma, the developer of namodenoson, is evaluating an earlier timing for the trial’s planned interim analysis, which would allow for an independent OS assessment between the namodenoson and placebo arms that is aligned with the study’s statistical analysis plan and relevant regulatory requirements.
“While the study remains blinded and these observations cannot predict the treatment effect of namodenoson, we believe that conducting the planned interim analysis earlier could provide important information regarding the potential clinical benefit of namodenoson in this patient population with substantial unmet medical need,” Motti Farbstein, chief executive officer and chief financial officer of Can-Fite, stated in the news release.
Namodenoson has been granted orphan drug designation in the United States and Europe, as well as fast track designation from the FDA as a second-line treatment for patients with HCC.²
LIVERATION is a multicenter, randomized, double-blind, placebo-controlled trial evaluating namodenoson vs placebo in patients with advanced HCC and underlying Child-Pugh class B7 cirrhosis whose disease has progressed on at least their first line of therapy.¹˒³ Patients needed to be at least 18 years of age, have Barcelona Clinic Liver Cancer stage B or C disease, have measurable disease by RECIST 1.1 criteria, and an ECOG performance status of 0 or 1.
LIVERATION Trial Updated OS Highlights
Patients were randomly assigned 2:1 to receive oral namodenoson at 25 mg or matching placebo twice daily in consecutive 28-day cycles, with treatment continuing until disease progression or unacceptable drug-related intolerability.³ Tumor imaging is being performed every 2 cycles.
OS serves as the trial’s primary efficacy end point. Secondary end points include progression-free survival, objective response rate, safety, and pharmacokinetics.
Namodenoson is a small, orally bioavailable molecule that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR).¹ A3AR is highly expressed in diseased cells, whereas low expression is found in normal cells; this differential expression may be one factor contributing to the safety profile of the drug.
The current LIVERATION program builds on earlier clinical experience with the agent in HCC. A prior randomized, placebo-controlled study of namodenoson in patients with advanced HCC and Child-Pugh B cirrhosis provided the rationale for the ongoing phase 3 trial in patients with Child-Pugh B7 disease.³
Beyond HCC, namodenoson is under investigation in gastrointestinal and metabolic diseases. In July 2026, the phase 2a study of namodenoson in patients with advanced pancreatic ductal adenocarcinoma (NCT06387342)
