RAMAT GAN, Israel, September 2, 2026
Can-Fite BioPharma Ltd. reported that blinded overall survival observed across the entire patient population in its ongoing pivotal Phase III study of Namodenoson in advanced hepatocellular carcinoma (HCC) appears longer than originally anticipated based on the assumptions used to design the trial. The company is now evaluating whether to advance the timing of the planned interim analysis, which could provide an earlier assessment of overall survival between the Namodenoson and placebo groups. The study remains blinded, meaning the currently observed survival data do not establish whether Namodenoson is responsible for the longer survival or demonstrate any difference between treatment arms.
Phase III Study Evaluates Namodenoson in Advanced HCC
The pivotal study is a randomized, double-blind, placebo-controlled Phase III trial evaluating Namodenoson in patients with advanced HCC and underlying Child-Pugh B7 cirrhosis, a population with significant disease burden and limited treatment options. Participants are randomized in a 2:1 ratio to receive Namodenoson or placebo, with overall survival serving as the primary efficacy endpoint. Can-Fite emphasized that the survival observation currently reflects the pooled, blinded population, including patients receiving both investigational treatment and placebo. Consequently, the company said no conclusions regarding treatment efficacy or differences between the two groups can be drawn until the planned interim analysis is conducted and the treatment assignments are evaluated according to the study’s statistical analysis plan.
Earlier Interim Analysis Could Provide Efficacy Insight
The longer-than-anticipated survival observed across the study population has prompted Can-Fite to assess whether the planned interim analysis can be performed earlier than originally expected. The analysis is intended to enable an independent assessment of overall survival between the Namodenoson and placebo arms in accordance with the predefined statistical framework and applicable regulatory requirements. An earlier analysis could provide important information on whether Namodenoson is demonstrating a potential clinical benefit in advanced HCC, although the company has not yet reported an efficacy result from the interim analysis. Can-Fite said the development is particularly relevant given the substantial unmet medical need among patients with advanced liver cancer and cirrhosis.
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Namodenoson Advances Across Liver and Cancer Programs
Namodenoson is an orally bioavailable small molecule designed to bind with high affinity and selectivity to the A3 adenosine receptor (A3AR). According to Can-Fite, A3AR is highly expressed in diseased cells while expression is comparatively low in normal cells, a mechanism the company believes may contribute to the candidate’s safety profile. In addition to the ongoing pivotal Phase III HCC program, Namodenoson has completed a Phase IIa study in pancreatic cancer and is being evaluated in a Phase IIb trial for metabolic dysfunction-associated steatohepatitis (MASH). The candidate has received Orphan Drug Designation in the United States and Europe and FDA Fast Track Designation for second-line treatment of HCC. The upcoming interim analysis is expected to be an important milestone in determining the next stage of Namodenoson’s clinical development in advanced liver cancer.
Source:Can-Fite BioPharma, press relese
