Can-Fite BioPharma Ltd. announced on Wednesday that its Phase 2a study of Namodenoson in advanced pancreatic ductal adenocarcinoma met its primary safety endpoint, with updated follow-up data showing durable overall survival in a subset of heavily pretreated patients. The findings support advancing the drug into a Phase 2b study combining Namodenoson with chemotherapy.
The open-label trial enrolled 20 patients whose disease had progressed after standard therapies. Fourteen received Namodenoson as third-line treatment, five as second-line therapy, and one as a fourth-line treatment. The company stated that Namodenoson was well tolerated, with a safety profile consistent with previous clinical studies.
Survival Analysis in Third-Line Cohort
Following an extended follow-up period, the company conducted an updated survival analysis in the third-line cohort. The analysis focused on eight patients who survived at least two months after starting treatment, excluding those with rapidly progressive disease who were considered unlikely to benefit from systemic therapy.
Among these eight evaluable patients, the median overall survival exceeded five months. The company reported that 62.5% of patients survived at least 5 months, while 37.5% survived at least 7 months. Two patients were still alive at the data cutoff, with one continuing to receive Namodenoson treatment and another followed for nearly nine months. The company also noted durable disease control, including progression-free survival extending beyond seven months.
| Metric |
Result |
| Patients in third-line cohort |
14 |
| Evaluable patients (survived >2 months) |
8 |
| Median overall survival |
>5 months |
| Survival rate at 5 months |
62.5% |
| Survival rate at 7 months |
37.5% |
Plans for Phase 2b Combination Study
Based on the updated results and discussions with the study's principal investigator, Can-Fite plans to advance Namodenoson into a Phase 2b study combining the drug with chemotherapy. The company said the decision was supported by recently published peer-reviewed preclinical data showing Namodenoson enhanced the anti-tumor activity of chemotherapeutic agents in pancreatic cancer models. The drug works by inhibiting multiple tumor proliferation and drug-resistance pathways while increasing cancer-cell sensitivity to chemotherapy.
The company also highlighted that among the five second-line patients, one remained alive more than 18 months after initiating Namodenoson, making that patient the longest survivor in the study.