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Targeting the A3 adenosine receptor to treat hepatocellular carcinoma: anti-cancer and hepatoprotective effects

Pnina Fishman1, Salomon M Stemmer2, Avital Bareket-Samish3

  • 1Can-Fite BioPharma Ltd., 10 Bareket St., 49170, Petah Tikva, Israel. Pnina@canfite.co.il.

Purinergic Signalling
|February 13, 2023
PubMed

Insights

Namodenoson, an A3 adenosine receptor agonist, shows potential in treating advanced hepatocellular carcinoma (HCC). While not meeting primary survival endpoints, it demonstrated promising results in specific patient subgroups, warranting further investigation.

Area of Science:

  • Oncology
  • Pharmacology
  • Hepatology

Background:

  • A3 adenosine receptor (A3AR) is over-expressed in human hepatocellular carcinoma (HCC).
  • Namodenoson, an A3AR agonist, targets Wnt and NF-kB signaling pathways to induce HCC cell apoptosis.
  • Previous studies indicated safety and tolerability of namodenoson in healthy volunteers and advanced HCC patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of namodenoson in patients with advanced HCC and Child-Pugh B (CPB) cirrhosis.
  • To assess the primary endpoint of overall survival (OS) superiority over placebo.
  • To explore subgroup efficacy, particularly in CPB7 patients.

Main Methods:

  • A phase II, blinded, randomized, placebo-controlled trial was conducted.
  • Patients with advanced HCC and CPB cirrhosis were enrolled.
  • Overall survival (OS) and progression-free survival (PFS) were key endpoints, with subgroup analyses performed.

Main Results:

  • The primary OS endpoint was not met.
  • Subgroup analysis of CPB7 patients showed a significant improvement in 12-month OS (44% vs 18%, p=0.028).
  • Partial response was observed in 9% of namodenoson-treated CPB7 patients versus 0% in placebo.

Conclusions:

  • Namodenoson did not meet the primary OS endpoint in advanced HCC with CPB cirrhosis.
  • A positive efficacy signal in the CPB7 subgroup suggests potential therapeutic benefit.
  • The favorable safety profile and preliminary efficacy support ongoing phase III studies for HCC treatment.
Keywords:
A3 adenosine receptorChild–Pugh BClinical studyHepatocellular carcinomaLiver cancerNamodenoson

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