Can-Fite BioPharma's Namodenoson Phase 2a Study Shows Prolonged Survival
Can-Fite BioPharma announced that its Phase 2a study evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma achieved its primary safety endpoint and demonstrated durable overall survival outcomes. The open-label Phase IIa study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had progressed following standard therapies. Fourteen patients received Namodenoson as third-line treatment, five as second-line treatment, and one as fourth-line treatment. Namodenoson was well tolerated, with a safety profile consistent with prior clinical trials. Following extended follow-up, an updated survival analysis was performed in the third-line population, focusing on the eight patients who survived at least two months after treatment initiation, thereby excluding patients with rapidly progressive disease unlikely to derive benefit from systemic therapy. Among the eight evaluable third-line patients: median overall survival exceeded 5 months; 62.5% of patients survived five months or longer; 37.5% survived seven months or longer; two patients remain alive at the data cutoff, including one patient continuing treatment and another followed for almost nine months and durable disease control was observed, including progression-free survival extending beyond seven months. The findings identify a subset of heavily pretreated pancreatic cancer patients achieving prolonged survival despite receiving Namodenoson as third-line therapy, supporting further clinical development of Namodenoson. Notably, among the five patients treated in the second-line setting, one patient remains alive more than 18 months after initiation of Namodenoson therapy, representing the longest survivor in the study. Based on these findings and discussions with the study's principal investigator, Can-Fite plans to advance Namodenoson into a Phase 2b combination study with chemotherapy.
