Namodenoson Meets Safety End Point in PDAC, Shows Durable Survival Outcomes Pretreated Subgroup

In addition to showing safety and tolerability in advanced pancreatic ductal adenocarcinoma (PDAC), the oral A3 adenosine receptor (A3AR) agonist namodenoson (CF102) showed durable disease control in a subset of heavily pretreated patients, according to updated survival analyses from a phase 2a trial (NCT06387342).¹

Of note, the agent was previously reported to have met the study’s primary safety end point in March 2026.²

Among the 8 evaluable third-line patients who survived at least 2 months after treatment initiation—a post hoc threshold applied to exclude individuals with rapidly progressive disease unlikely to benefit from systemic therapy—the median overall survival (OS) exceeded 5 months.¹ Moreover, 62.5% survived 5 months or longer, and 37.5% survived 7 months or longer. At the data cutoff, 2 patients in the third-line group remained alive, including 1 patient who continued treatment and another who was followed for almost 9 months. Durable disease control was reported in this subset, with progression-free survival extending beyond 7 months. Of the 5 patients treated in the second-line setting, 1 remained alive more than 18 months after starting namodenoson.

No new safety signals were identified in the updated analysis, and namodenoson continued to be well tolerated across the third-, second-, and fourth-line populations evaluated.^1,2 The safety profile remains consistent with namodenoson's known clinical experience in other oncologic diseases.

Whether these outcomes represent a clinically meaningful improvement over historical benchmarks in third-line PDAC, where median OS is generally measured in weeks to a few months, remains to be established in a controlled trial.¹

“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 favorable safety profile together with the prolonged survival observed in a subgroup of patients suggest biological activity worthy of further investigation,” Salomon Stemmer, MD, professor at the Davidoff Institute of Oncology at Rabin Medical Center in Israel, who is leading the phase 2a study, stated in a news release. “Based on these findings and the growing preclinical evidence demonstrating enhancement of chemotherapy activity, I believe the next logical step is evaluation of namodenoson in combination with chemotherapy.”

How was the phase 2a study designed?

The open-label, single-arm, phase 2a study enrolled 20 patients with advanced PDAC who had progressed on at least 1 prior systemic treatment regimen. Eligible patients received namodenoson at a dose of 25 mg orally twice daily in continuous 28-day cycles.³ Overall, 14 patients received namodenoson as third-line treatment, 5 as second-line treatment, and 1 as fourth-line treatment. After extended follow-up, an updated survival analysis focused on the third-line cohort was conducted.

The study's primary end point was safety; OS was assessed as an exploratory efficacy measure.

Where is namodenoson in the clinical development pipeline?

Namodenoson, which was previously granted orphan drug designation in both the United States and Europe for hepatocellular carcinoma (HCC), as well as fast track designation from the FDA as a second-line treatment for HCC, is now being evaluated across multiple oncologic indications.

Preclinical data supporting the combination of namodenoson with chemotherapy in pancreatic cancer models were recently published in a peer-reviewed journal; results demonstrated that namodenoson enhances the antitumor activity of chemotherapeutic agents by simultaneously inhibiting the Wnt/β-catenin and Hedgehog signaling pathways and reducing expression of multidrug-resistance proteins, thereby increasing chemosensitivity in PDAC cell lines.

Based on the phase 2a results and the mechanistic rationale established by preclinical data, Can-Fite BioPharma has announced plans to advance namodenoson into a phase 2b combination study with chemotherapy in pancreatic cancer.

References

1. Can-Fite phase 2a pancreatic cancer study with namodenoson achieves primary safety endpoint and demonstrates durable survival outcomes in advanced disease. News release. Can-Fite BioPharma Ltd. July 1, 2026. Accessed July 1, 2026. https://ir.canfite.com/news-events/press-releases/detail/1117/can-fite-phase-2a-pancreatic-cancer-study-with-namodenoson
2. Can-Fite's namodenoson successfully meets primary endpoint in phase 2a pancreatic cancer study. News release. Can-Fite BioPharma. March 4, 2026. Accessed July 1, 2026. https://ir.canfite.com/news-events/press-releases/detail/1105/can-fites-namodenoson-successfully-meets-primary