Can-Fite BioPharma announced that the phase 2 study of their advanced liver cancer candidate, Namodenoson, did not achieve its primary endpoint of overall survival, according to a press release.
However, investigators noted a superiority in overall survival among a subpopulation of patients with Child-Pugh B cirrhosis and secondary endpoints.
“Given the evidence of Namodenoson’s clinical benefit, I plan on offering it to selected [hepatocellular carcinoma Child-Pugh B] patients in the compassionate use setting,” Salomon M. Stemmer, MD, principal investigator from Tel Aviv University Israel, said in the release.
The study comprised 78 patients with advanced liver cancer and Child-Pugh B cirrhosis that had not improved with Nexavar (sorafenib, Bayer) treatment. The investigators divided patients into three categories of increasing severity, with 56 patients in the first group, all of whom received Namodenoson or placebo.
For the whole population, median overall survival was not superior to placebo (4.1 vs. 4.3 months), whereas overall survival in the first subgroup of patients was 6.8 months (HR = 0.77; 95% CI, 0.49-1.4). Additionally, progression-free survival was 3.5 months in patients from the first subgroup who received treatment compared with 1.9 months in the placebo group.
Nine percent of treated patients achieved partial response compared with none in the placebo group. Disease control rate was higher in treated patients than controls (18% vs. 7.1%; P = .013) after 4 months of treatment. Two treated patients are currently ongoing after 19 months and 28 months, respectively.
Namodenoson was generally well-tolerated with no discontinuations or treatment-related deaths.
“We are encouraged by the advantage shown by Namodenoson in the [first subgroup] HCC population, a group for which there are no drugs with proven effectiveness,” Pnina Fishman, CEO of Can-Fite, said in the release. “Since Namodenoson has a favorable safety profile and shows no evidence of hepatotoxicity, it may possess a unique therapeutic index in this high-need population. Given that Namodenoson has been granted Fast Track status by the FDA, we look forward to engaging regulatory authorities in a dialog at the earliest opportunity.”