JERUSALEM, Israel — Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) (“Alpha Tau”), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced the presentation of updated pooled results from two first-in-human clinical trials of Alpha DaRT in pancreatic ductal adenocarcinoma (PDAC) at Digestive Disease Week (DDW) 2026, the world’s premier international gastroenterology conference.
The abstract, entitled “Updated Results of Feasibility, Safety, and Tumor Control in Two First-In-Human Trials of a Novel Alpha-Emitting Radionuclide for Pancreatic Adenocarcinoma,” was selected for podium presentation in the Pancreatic Cancer I: Diagnosis and Treatment session. The abstract is based on combined data from two clinical protocols conducted at Hadassah Medical Center in Jerusalem, Israel, and was presented by Philip Blumenfeld, MD, Director of Advanced Radiotherapy Unit, Sharett Institute of Oncology, Hadassah Medical Center. This marks the first time that Alpha DaRT clinical results have been selected for oral presentation at a major gastroenterology conference.
Clinical Results
The results were pooled from two clinical studies of Alpha DaRT treating localized unresectable and metastatic pancreatic cancers in a heterogeneous patient population, including those who were ineligible to receive chemotherapy as well as those who had undergone up to four prior lines of chemotherapy. Despite this breadth and complexity of clinical backgrounds, 100% local disease control was achieved across all 19 evaluable patients based on modified RECIST v1.1 criteria, as measured by best overall response, reflecting 15 (79%) with stable disease and 4 (21%) with partial response, a landmark result underscoring the potential of Alpha DaRT as a compelling intratumoral treatment regardless of prior treatment history.
The safety profile was also highly encouraging. Among 26 subjects treated, only 8 device-associated adverse events were observed in 7 subjects (27%), all of which resolved within two weeks, with the exception of one instance of lingering fatigue.
Uzi Sofer, CEO of Alpha Tau, stated: “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. What makes these data particularly compelling is not only the efficacy and safety signal – which are both exceptional – but also the fact that this treatment was designed to integrate naturally into the existing patient pathway and GI workflow. The ability to deliver Alpha DaRT via EUS, a procedure which gastroenterologists already perform routinely, makes this treatment highly attractive from a clinical adoption perspective. Furthermore, the combination of a localized treatment with systemic approaches represents a major advantage over combinations of other systemic therapies with chemotherapy regimens, which often carry significant toxicity burdens. 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.”
“These are some of the most challenging, heavily pre-treated patients in oncology – patients for whom available options are extremely limited,” commented Robert Den, MD, Chief Medical Officer of Alpha Tau. “Nevertheless, consistency of response across such a diverse cohort is a powerful signal of Alpha DaRT’s potential. Coupled with a very promising safety profile characterized by low rates of device-associated adverse events and rapid resolution, these results provide a strong foundation for the advancement of Alpha DaRT in pancreatic cancer and further reinforce the scientific basis for our ongoing U.S. multicenter pancreatic cancer IMPACT trial.”
Philip Blumenfeld, MD, Director of Advanced Radiotherapy Unit, Sharett Institute of Oncology, Hadassah Medical Center, and presenter of the abstract, commented: “As a radiation oncologist and member of a multidisciplinary pancreatic cancer team, I see these results as potentially addressing a significant unmet need from several clinical perspectives. Pancreatic cancer has historically been relatively resistant to radiation therapy, and while modern techniques such as SBRT have improved our ability to deliver ablative doses, their use remains constrained by the close proximity of critical gastrointestinal structures. As a result, achieving meaningful local control without toxicity continues to be a major challenge. The ability to deliver intratumoral alpha-particle therapy via EUS, with consistent disease control across treated patients, hopefully represents an important advance in the radiotherapeutic management of this disease. Equally notable is the favorable toxicity profile. In a patient population already heavily burdened by aggressive systemic chemotherapy, a treatment that offers strong local efficacy with minimal added toxicity is highly compelling. This combination makes Alpha DaRT a treatment I am genuinely excited about for my patients.”
About Alpha DaRT®
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University. To learn more visit https://www.alphatau.com/.
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