On August 31, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the completion of patient enrollment in its IMPACT study (Intratumoral Pancreatic Alpha Combination Trial) – a multicenter pilot study evaluating intratumoral Alpha DaRT in combination with first-line chemotherapy for patients with newly diagnosed, unresectable locally advanced or metastatic pancreatic adenocarcinoma. A total of 48 patients have been enrolled.
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Pancreatic cancer is the third leading cause of cancer-related death in the United States, with approximately 66,000 new cases diagnosed each year, and with up to 87% of patients considered inoperable at diagnosis. For these patients, treatment is built around systemic chemotherapy, and the benefit available from existing therapies remains limited.
The IMPACT study comes after first-in-human Alpha DaRT studies conducted at Hadassah Medical Center in Jerusalem, Israel, and at the Jewish General Hospital and the Centre Hospitalier de l’Université de Montréal (CHUM) in Montreal, Canada, the results of which were presented earlier this year at the 2026 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, Digestive Disease Week (DDW) 2026 and at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. The favorable safety profile observed in those studies gave support to delivering Alpha DaRT as a one-time addition to first-line mFOLFIRINOX or gemcitabine + nab-paclitaxel (Abraxane) chemotherapy, given at full systemic dose, at the start of a patient’s chemotherapy treatment.
IMPACT was originally approved to enroll 12 patients, and was subsequently expanded three times, the third time at the request of participating clinical sites, to include patients across multiple disease stages and patients receiving either of the two leading first-line chemotherapy regimens. The study now moves from recruitment into follow-up and data maturation, with initial data targeted for early 2027, intended to inform the design of a planned pivotal study.
Uzi Sofer, CEO of Alpha Tau, stated: "The rate at which enrollment was completed in the IMPACT study is simply astounding and is probably the fastest enrollment of a study in my memory as CEO. This is a major milestone for Alpha Tau and for our pancreatic cancer program. Pancreatic cancer is one of the cruelest diagnoses in oncology, and it has been a core strategic focus for this Company. Our investigators in Israel and Canada showed that Alpha DaRT can be delivered safely and without the heavy safety profile of systemic therapies, and that is what gave us, and our physicians the confidence to introduce it to patients at the beginning of their treatment – as a one-time addition to the chemotherapy they are already receiving, rather than something chosen in lieu of chemotherapy. Notably, this approach is not limited to a given study and can potentially be applied even as the systemic standard of care in this disease continues to evolve. We continue to see new systemic therapies emerge in the treatment of this terrible disease, which is wonderful news for patients and their loved ones, and we hope to one day explore the combination of Alpha DaRT with further best-in-class treatments. I want to thank every one of the participating centers for the focus and the commitment they brought to this study and am excited now to shift our energies towards the pivotal study."
Dr. Robert Den, Chief Medical Officer of Alpha Tau, added: "IMPACT is the product of everything that came before it. The first-in-human trials in Jerusalem and Montreal established that Alpha DaRT can be delivered into the pancreas with a favorable safety profile which is compatible with full-dose systemic therapy given concurrently – overcoming the historical obstacle to using local therapy in this setting. IMPACT tests that question directly, in newly diagnosed patients and across both leading first-line regimens, and it is one of three studies now advancing, alongside the ACAPELLA trial in Europe, evaluating Alpha DaRT as consolidation following first-line mFOLFIRINOX, and our study at the University of Verona’s Pancreas Institute, which extends the program to percutaneous delivery. These are not stand-alone efforts; each one builds on the evidence generated by the last. I want to express my sincere gratitude to the investigators and to the patients taking part in IMPACT, whose commitment has brought us to this milestone."
About the IMPACT Study
IMPACT (Intratumoral Pancreatic Alpha Combination Trial) is a prospective, multicenter, open-label pilot study evaluating the feasibility, safety and efficacy of intratumoral Alpha DaRT in combination with first-line standard-of-care chemotherapy for the treatment of patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma. The study is conducted under a U.S. Investigational Device Exemption (IDE) and enrolled 48 patients across two cohorts, locally advanced disease and metastatic disease, at 10 clinical centers in the United States, Canada and Israel. Eligible patients had newly diagnosed, histologically confirmed pancreatic adenocarcinoma that was inoperable and non-irradiated, and were either chemotherapy-naïve or within the first four cycles of initial chemotherapy. Patients continue to receive standard-of-care chemotherapy throughout the study, either mFOLFIRINOX or gemcitabine in combination with Abraxane (nab-paclitaxel), and Alpha DaRT sources are inserted into the primary tumor under real-time endoscopic ultrasound (EUS) guidance. Follow-up continues for up to six months after enrollment. The primary objective is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of treatment-emergent Adverse Events (TEAS), classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Secondary objectives include the assessment of: (1) efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival, (2) pain control, and (3) in the locally advanced cohort, rate of surgical resection. Additional information about the study is available at View Source
(Press release, Alpha Tau Medical, AUG 31, 2026, View Source [SID1234670475])