Namodenoson Achieves Longer-Than-Anticipated Survival in Advanced HCC

Blinded overall survival (OS) observed across the entire patient population enrolled in the ongoing pivotal phase 3 LIVERATION trial (NCT05201404) of namodenoson in patients with advanced hepatocellular carcinoma (HCC) appears longer than originally anticipated based on the assumptions underlying the study design, according to a news release from the developer, Can-Fite BioPharma.¹ In response, the company is evaluating an earlier timing for the trial's planned interim analysis.

What survival findings came from the LIVERATION trial?

The observed survival reflects the pooled, blinded study population and includes patients who received both namodenoson and placebo. Accordingly, no conclusions regarding treatment efficacy or differences between the study arms can be drawn from these data at this stage. In view of the longer-than-anticipated survival observed across the study population, the company is evaluating an earlier timing for the trial's planned interim analysis. This would enable an independent assessment of OS between the namodenoson and placebo groups in accordance with the study's statistical analysis plan and applicable regulatory requirements.

“We are encouraged by the longer overall survival being observed among patients participating in this pivotal study,” stated Motti Farbstein, chief executive officer and chief financial officer of Can-Fite BioPharma, in the press release.¹ “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.”

How is the phase 3 LIVERATION trial designed?

LIVERATION is a randomized, double-blind, placebo-controlled phase 3 study evaluating namodenoson in patients with advanced HCC and underlying Child-Pugh B7 cirrhosis. Patients were randomly assigned 2:1 to receive namodenoson at 25 mg orally twice daily or matching placebo, both administered until disease progression or unacceptable toxicity.²

Eligible patients are 18 years or older and must have disease that has progressed on at least 1, but no more than 2, prior systemic treatment regimens. Those who do not have cirrhosis at the time of diagnosis were required to have histologic confirmation, and for those who do have underlying cirrhosis at the time of diagnosis, disease had to meet criteria of American Association for the Study of Liver Diseases Practice Guideline algorithm (Marrero 2018). Additionally, patients had advanced disease for which no standard therapies are expected to be curative, an ECOG performance status of 1 or lower, and measurable disease per RECIST v1.1.

The primary efficacy end point is OS. Secondary end points include progression-free survival, overall response rate, safety, and pharmacokinetics.

What is namodenoson and how does it work?

Namodenoson is a small, orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Because A3AR is highly expressed in diseased cells but shows low expression in normal cells, this differential expression is considered a key factor in the agent's favorable safety profile.

Beyond the LIVERATION trial, namodenoson previously completed a phase 2a study (NCT06387342) in pancreatic cancer that showed durable survival outcomes in a subset of heavily pretreated patients,³ and the drug is currently enrolling patients in a phase 2b trial evaluating its use in metabolic dysfunction–associated steatohepatitis (MASH).

What is namodenoson's regulatory history in liver cancer?

Namodenoson has been granted orphan drug designation in the United States and Europe, along with fast track designation from the FDA as a second-line treatment for HCC. The drug has also shown proof-of-concept activity in other tumor types, including colon, prostate, and melanoma cancers.

References

1. Can-Fite reports longer-than-anticipated overall survival in ongoing pivotal Phase III liver cancer study. News release. Can-Fite BioPharma Ltd. September 2, 2026. Accessed September 3, 2026. https://tinyurl.com/bdh88prv
2. Namodenoson in the treatment of advanced hepatocellular carcinoma in patients with Child-Pugh Class B7 cirrhosis (LIVERATION). ClinicalTrials.gov. Updated April 29, 2025. Accessed September 3, 2026. https://tinyurl.com/4aazdn2d
3. Can-Fite phase 2a pancreatic cancer study with namodenoson achieves primary safety endpoint and demonstrates durable survival outcomes in advanced disease. News release. Can-Fite BioPharma Ltd. July 1, 2026. Accessed September 3, 2026. https://tinyurl.com/2x787bdt