Alpha Tau Medical Ltd. (NASDAQ: DRTS) reported that pooled data from two first‑in‑human trials of its Alpha DaRT platform in pancreatic ductal adenocarcinoma achieved a 100% local disease control rate in all 19 evaluable patients. The trials, conducted at Hadassah Medical Center, enrolled heavily pre‑treated patients—some ineligible for chemotherapy and others having received up to four prior lines of therapy. Of the 26 subjects treated, 15 showed stable disease and 4 achieved partial response under modified RECIST v1.1 criteria. Device‑associated adverse events occurred in 8 patients (27% of the cohort) and resolved within two weeks, except for one case of lingering fatigue.
The presentation of these results took place on May 2, 2026, during the Digestive Disease Week (DDW) conference in Chicago. Alpha DaRT delivers radium‑224 directly into tumors via an endoscopic ultrasound‑guided procedure, a short‑range alpha‑particle therapy that spares surrounding tissue. The 100% local disease control rate in such a difficult-to‑treat population underscores the platform’s potency and safety profile, both critical factors for regulatory approval and clinical adoption.
Alpha Tau’s data position the Alpha DaRT platform as a potentially transformative option for pancreatic cancer, a disease with limited effective therapies. The high local control rate, coupled with a favorable safety profile, may accelerate discussions with regulators and support the company’s strategy to expand Alpha DaRT into other high‑need indications. The results also strengthen the case for the ongoing U.S. IMPACT trial and the European ACAPELLA trial, both of which are designed to evaluate Alpha DaRT in combination with standard chemotherapy regimens.
CEO Uzi Sofer said, “These results represent a highly significant milestone for Alpha DaRT and for Alpha Tau’s strategic mission to establish intratumoral alpha‑emitting radiotherapeutics as a meaningful option in oncology’s most challenging indications.” Chief Medical Officer Robert Den added, “We believe Alpha DaRT has the potential to fundamentally change how pancreatic cancer is treated, and these results bring us closer to realizing that potential.”
Prior data from a pilot study of five patients demonstrated feasibility and safety, while a January 2026 study reported a 22% objective response rate and an 81% disease control rate in 32 patients. Alpha Tau filed a Form F‑3 shelf registration to offer up to $300 million of securities six business days before the DDW presentation, and the company reported a net loss of $42.6 million for 2025 with $76.9 million in cash and cash equivalents, providing a financial cushion for continued development.
The 100% local disease control rate in a heavily pre‑treated cohort, combined with a low incidence of serious adverse events, signals a significant advance for Alpha Tau’s Alpha DaRT platform. For investors, the data reinforce the company’s growth trajectory and its potential to secure regulatory approval, which could unlock substantial commercial opportunities in a high‑need market.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.