Key Highlights

  • Can-Fite BioPharma presented final Phase IIa data for namodenoson in pancreatic cancer at ESMO 2026.
  • The study met its primary safety endpoint, with only five treatment-related or possibly related events in three patients.
  • In an exploratory third-line analysis of eight patients, median overall survival was 6.28 months.
  • One second-line patient reached 16.39 months of progression-free survival and 20.7 months of overall survival.

Can-Fite BioPharma Ltd. presented final data from its Phase IIa study of namodenoson in advanced pancreatic ductal adenocarcinoma at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid on 26 October 2026. The Israeli biotechnology company reported that the study achieved its primary safety endpoint and described exploratory survival findings in heavily pretreated patients.

Study Design and Safety Findings

The single-center, open-label study enrolled 20 patients who received oral namodenoson at 25 mg twice daily. Fourteen were treated in the third-line setting, three in the second-line setting and three in the fourth-line setting. All had received prior systemic therapy.

Only five adverse events in three patients were considered related or possibly related to the drug. All were Grade 1 to 2, none required a dose change, interruption or discontinuation, and no Grade 3 or higher treatment-related events or treatment-related serious adverse events were reported.

Exploratory Findings and Drug Background

In a post hoc analysis of eight third-line patients who survived beyond two months, median overall survival was 6.28 months and median progression-free survival was 2.27 months. The company said the analysis focused on patients who survived beyond two months to allow sufficient treatment exposure, and that because the subgroup was selected on survival and the study had no randomized comparator, the findings are hypothesis-generating.

One second-line patient achieved progression-free survival of 16.39 months and overall survival of 20.7 months as of the 23 September 2026 data cutoff.

Namodenoson is an orally administered, selective agonist of the A3 adenosine receptor, which is highly expressed in tumor and inflammatory cells. Can-Fite says it modulates growth-regulatory signalling pathways, including Wnt/β-catenin and RAS-associated signalling, and promotes tumor-cell apoptosis. The drug is in a pivotal Phase 3 trial for advanced liver cancer and a Phase 2b trial for metabolic dysfunction-associated steatohepatitis.

The company is dual-listed on the NYSE American and the Tel Aviv Stock Exchange under the ticker CANF. The release reproduced the full scientific poster presented at ESMO and made it available as a downloadable PDF. A professor at the Davidoff Institute of Oncology, Rabin Medical Center, was quoted describing the safety profile and survival findings as supporting continued clinical development.

Why This Could Matter

The release closes out the Phase IIa pancreatic cancer program with a defined safety result and survival figures drawn from small subgroups. The company states that the data support evaluation in a larger randomized study, and the exploratory numbers carry the selection caveats the company itself describes. For Can-Fite, pancreatic cancer is one of three indications named for namodenoson, alongside liver cancer and steatohepatitis.

The 20-patient size, the open-label single-center design and the post hoc nature of the third-line analysis are the features that the company itself cites when calling the survival findings hypothesis-generating. The primary endpoint was safety, and the reported treatment-related events were limited to five events in three patients.

The Bottom Line

Can-Fite reported a completed Phase IIa study with a met safety endpoint, a 20-patient dataset and exploratory survival results from selected patients. Further development in pancreatic cancer would require a larger randomized trial.