Can-Fite has reported that its Phase IIa study of Namodenoson in advanced pancreatic ductal adenocarcinoma patients achieved its primary safety endpoint.
The open-label study also showed durable overall survival outcomes.
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It enrolled 20 advanced pancreatic ductal adenocarcinoma patients who had progressed on standard therapies, with 14 receiving Namodenoson as third-line treatment, five as second-line and one as fourth-line.
Namodenoson showed a tolerable safety profile consistent with previous studies.
Extended follow-up and updated survival analysis focused on the third-line group, particularly on eight patients who survived at least two months from the onset of treatment, thereby excluding those with rapid progression.
Among these eight third-line patients, median overall survival was more than five months, with 62.5% surviving at least five months and 37.5% surviving seven months or more than that.
Two patients in the trial remained alive at the data cut-off, including one still on treatment and another monitored for almost nine months. Notably, some patients experienced progression-free survival extending beyond seven months.
These findings highlight a subgroup of heavily pretreated pancreatic cancer patients achieving extended survival with Namodenoson as third-line therapy, supporting the continuation of its clinical development.
In second-line treatment, one patient remained alive beyond 18 months after starting Namodenoson, the study’s longest survivor.
Davidoff Institute of Oncology, Rabin Medical Center, Israel, oncology key opinion leader professor Salomon Stemmer is leading the Phase IIa study.
Stemmer said: “Pancreatic cancer remains one of the most difficult malignancies to treat, particularly after failure of standard therapies.
“The results of Namodenoson monotherapy are impressive and the favourable safety profile, together with the prolonged survival observed in a subgroup of patients, suggest biological activity worthy of further investigation.”
Based on these results, Can-Fite plans to progress into a Phase IIb combination study of Namodenoson and chemotherapy.
Namodenoson is an orally administered drug binding selectively to the A3 adenosine receptor (A3AR), currently in Phase III for liver cancer, concluded Phase IIa for pancreatic cancer, and enrolling in Phase IIb for metabolic dysfunction-associated steatohepatitis.
The drug’s safety profile is attributed to its selective targeting of diseased cells expressing higher A3AR levels.
