Namodenoson (CF102) demonstrated durable overall survival (OS) outcomes in a small subset of pretreated patients with advanced pancreatic ductal adenocarcinoma (PDAC) in an updated analysis from a phase 2a trial (NCT06387342), according to a news release from the developer, Can-Fite BioPharma Ltd.1 The oral A3 adenosine receptor (A3AR) agonist previously met its primary safety end point in the same study.2 Based on these findings and growing preclinical evidence of enhanced chemosensitivity, the developer plans to advance namodenoson into a phase 2b combination study with chemotherapy.
What survival outcomes were observed with namodenoson in PDAC?
The open-label phase 2a study enrolled 20 patients with advanced PDAC who had progressed following standard therapies: 14 received namodenoson as third-line treatment, 5 as second-line treatment, and 1 as fourth-line treatment. Following extended follow-up, an updated survival analysis focused on 8 evaluable third-line patients who survived at least 2 months after treatment initiation.
Among the 8 patients, the median OS exceeded 5 months; 62.5% of patients survived 5 months or longer and 37.5% survived 7 months or longer. At the data cutoff, 2 patients remained alive, including 1 who continued treatment and another followed for almost 9 months. Among the 5 patients treated in the second-line setting, 1 remained alive more than 18 months after starting namodenoson.
“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,” stated Salomon Stemmer, MD, professor at the Davidoff Institute of Oncology at Rabin Medical Center in Israel, who is leading the phase 2a study, in the press release.1 “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.”
What was the design of the phase 2a namodenoson trial?
The trial enrolled adults with advanced PDAC who had progressed on at least 1 prior systemic treatment regimen, with namodenoson dosed at 25 mg orally twice daily in continuous 28-day cycles.3 The study met its primary end point of safety and tolerability, with no new safety signals identified and a profile consistent with namodenoson’s known clinical experience in other oncologic diseases.² That safety finding held in the current update: namodenoson continued to be well tolerated across the third-, second-, and fourth-line populations evaluated.
What is namodenoson and how does it work?
Namodenoson is a small, orally bioavailable drug that binds with high affinity and selectivity to A3AR. Because A3AR is highly expressed on diseased cells but has low expression on normal cells, this differential expression is considered a key factor in the agent’s favorable safety profile. Namodenoson is also being evaluated in a pivotal phase 3 trial for advanced liver cancer, and has proof-of-concept data in other tumor types including colon cancer, prostate cancer, and melanoma.
What are the next steps for namodenoson in pancreatic cancer?
Based on the survival findings and discussions with the study’s principal investigator, the developer plans to advance namodenoson into a phase 2b combination study with chemotherapy. The decision follows recently published preclinical data showing that namodenoson enhances the antitumor activity of chemotherapeutic agents in pancreatic cancer models by inhibiting multiple tumor proliferation and drug-resistance pathways, including Wnt/β-catenin and Hedgehog signaling, while reducing expression of multidrug-resistance proteins.4
References
- 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://tinyurl.com/2x787bdt
- 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://tinyurl.com/9ncjhymy
- Namodenoson treatment of advanced pancreatic cancer. ClinicalTrials.gov. Updated January 31, 2025. Accessed July 1, 2026. https://tinyurl.com/4p326484
- Itzhak I, Bareket-Samish A, Fishman P. Namodenoson inhibits the growth of pancreatic carcinoma via deregulation of the Wnt/β-catenin, NF-κB, and RAS signaling pathways. Biomolecules. 2023;13(11):1584. Published October 27, 2023. doi:10.3390/biom13111584
