Can-Fite’s Namodenoson Phase 2a Trial Shows >5-Month Median Survival, 37.5% 7-Month Rate
CANF•Can-Fite BioPharma's Phase 2a Namodenoson trial in 20 advanced pancreatic cancer cases achieved its primary safety endpoint, with the third-line cohort showing median overall survival beyond five months and 37.5% surviving over seven months. One second-line patient remains alive at 18+ months, prompting a Phase 2b combination study.
1. Study Design and Safety Endpoint
Phase 2a open-label study enrolled 20 patients with advanced pancreatic ductal adenocarcinoma who had failed standard therapies, including 14 in third-line, five in second-line and one in fourth-line settings, and achieved its primary safety endpoint with Namodenoson well tolerated and safety consistent with prior trials.
2. Third-Line Survival Outcomes
In the evaluable third-line cohort of eight patients surviving beyond two months, median overall survival exceeded five months, 62.5% survived at least five months, 37.5% survived beyond seven months, and two patients remained alive at data cutoff, one after almost nine months of follow-up.
3. Second-Line Durable Response
Among five second-line patients, one individual remains alive more than 18 months after initiating Namodenoson monotherapy, marking the longest survival in the study and suggesting potential benefit earlier in treatment sequencing.
4. Planned Phase 2b Combination Trial
Based on these durable survival and safety results and preclinical evidence that Namodenoson enhances chemotherapy activity, Can-Fite plans to advance the drug into a Phase 2b combination trial with chemotherapy in pancreatic cancer.
