Can-Fite BioPharma’s Phase 2a trial of Namodenoson in advanced pancreatic ductal adenocarcinoma met its safety endpoint and showed prolonged survival in select patients, supporting a planned Phase 2b combination study.
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
Can-Fite BioPharma has reported updated results from its Phase 2a trial (NCT06387342) evaluating Namodenoson in patients with advanced pancreatic ductal adenocarcinoma (PDAC) who had progressed after standard treatment. The open-label study met its primary safety endpoint and showed prolonged overall survival in a subset of patients receiving the investigational therapy, despite treatment in later lines of disease.
Among 20 enrolled patients, 14 received Namodenoson as third-line therapy, five as second-line treatment, and one as fourth-line treatment. The oral therapy was well tolerated, with no new safety concerns and an adverse event profile consistent with previous clinical studies.
Targeting the A3 Adenosine Receptor in Pancreatic Cancer
Namodenoson is an orally available, highly selective A3 adenosine receptor (A3AR) agonist. The receptor is overexpressed in several malignant and inflammatory cells while remaining minimally expressed in normal tissues, providing a biological rationale for selective antitumor activity with limited systemic toxicity.
Pancreatic ductal adenocarcinoma remains one of the deadliest solid tumors, and treatment options become extremely limited after failure of first-line therapy. Patients receiving third-line treatment typically have poor survival, making durable disease control an important clinical objective.
Phase 2a Data Showed Durable Survival in a Subgroup of Third-Line Patient
Following extended follow-up, investigators analyzed outcomes in eight evaluable third-line patients who survived at least two months after starting treatment, excluding patients with rapidly progressive disease. In this subgroup, median overall survival exceeded five months, with 62.5% of patients surviving at least five months and 37.5% remaining alive for seven months or longer. At the data cutoff, two patients were still alive, including one who continued receiving Namodenoson and another who had been followed for nearly nine months. The study also demonstrated durable disease control, with progression-free survival extending beyond seven months in some patients.
The study also identified a notable response in the second-line cohort, where one patient survived beyond 18 months after initiating Namodenoson, representing the longest survivor in the trial.
Combination Strategy Supported by Clinical and Preclinical Evidence
Principal investigator Prof. Salomon Stemmer of the Davidoff Institute of Oncology, Rabin Medical Center, said the favorable safety profile and prolonged survival observed in selected patients suggest meaningful biological activity in advanced pancreatic cancer. He noted that combining Namodenoson with chemotherapy represents the logical next step given emerging evidence supporting enhanced treatment activity.
Recently published preclinical research demonstrated that Namodenoson increased the antitumor activity of chemotherapy in pancreatic cancer models by suppressing multiple pathways involved in tumor growth and drug resistance, including Wnt/β-catenin and Hedgehog signaling. The therapy also reduced multidrug-resistance protein expression and improved chemotherapy sensitivity in pancreatic cancer cells.
Phase 2b Combination Trial Planned
Based on the clinical findings and supportive mechanistic data, Can-Fite plans to advance Namodenoson into a Phase 2b trial evaluating the drug in combination with chemotherapy for advanced pancreatic cancer.
Beyond PDAC, Namodenoson is currently being evaluated in a Phase 3 trial for advanced hepatocellular carcinoma and a Phase 2b trial in metabolic dysfunction-associated steatohepatitis (MASH). The therapy has received U.S. FDA Fast Track designation for second-line hepatocellular carcinoma and Orphan Drug designation in both the United States and Europe, reflecting its broader development potential across difficult-to-treat diseases. If validated in upcoming combination studies, Namodenoson could emerge as a novel therapeutic option for patients with advanced pancreatic cancer, a setting with few effective treatments.
What This Means for Patients
For patients with advanced pancreatic cancer who have exhausted standard treatment options, effective therapies are extremely limited and survival is often measured in months. Although these findings come from a small early-stage study, the durable survival observed in a subset of heavily pretreated patients, together with Namodenoson’s favorable safety profile, suggests it may offer meaningful clinical benefit for some individuals. The planned Phase 2b combination trial will determine whether these encouraging results can be confirmed in a larger patient population.
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About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.