Alpha Tau Medical Ltd. disclosed that its 32‑patient, endoscopic ultrasound‑guided pilot study in Montreal achieved an 81% disease‑control rate (87% when the first two low‑dose patients are excluded) and a 22% objective‑response rate, the first published clinical outcomes for the Alpha DaRT platform in pancreatic cancer.
The disease‑control rate, which includes stable disease and partial responses, compares favorably to historical benchmarks for this hard‑to‑treat tumor, where conventional therapies typically yield disease‑control rates below 50%. Excluding the two low‑dose patients—who received a sub‑therapeutic dose—raises the rate to 87%, underscoring the importance of dose optimization in this early‑stage trial.
Immune‑marker analysis revealed no significant changes in neutrophil‑to‑lymphocyte, platelet‑to‑lymphocyte, CD4/CD8 ratios or C‑reactive protein one month after treatment, while IL‑6 levels dropped dramatically. The sustained low‑inflammatory profile suggests that Alpha DaRT delivers potent alpha‑particle therapy while sparing surrounding healthy tissue and preserving systemic immune function, a key differentiator from conventional radiation.
The results are a critical milestone for Alpha Tau’s clinical pipeline. They provide early evidence of safety, feasibility and encouraging disease control that will inform the company’s U.S. multi‑center IMPACT trial and future regulatory submissions. The data also support the company’s strategy to expand Alpha DaRT into other hard‑to‑treat solid tumors, potentially broadening its commercial portfolio.
CEO Uzi Sofer emphasized that pancreatic cancer remains a cornerstone of Alpha Tau’s strategy, noting that the trial “demonstrates the platform’s potential to deliver meaningful clinical benefit while maintaining an immune‑preserving profile.” He added that the company is “forging ahead toward a potential future approval in this key indication.” The market reacted positively, reflecting confidence in the data and the company’s regulatory progress, including a recent FDA PMA submission for cutaneous squamous cell carcinoma.
Alpha Tau’s financial health remains solid, with $75.9 million in cash and equivalents as of September 30, 2025, providing a runway to support ongoing clinical development and regulatory activities. The company’s recent earnings report showed a net loss of $30.5 million for Q3 2025, but the cash position and clinical milestones position Alpha Tau to pursue accelerated development pathways in the coming years.
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