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Alpha DaRT PDAC — EUS-guided intratumoral Alpha DaRT (diffusing alpha-emitter radiation therapy), locally advanced or metastatic pancreatic ductal adenocarcinoma, 2L+

Abstract: # not published in press materials · Session: Gastrointestinal Cancer — Pancreatic (poster), 2026 ASCO Annual Meeting, May 29 – Jun 2, 2026 (exact date/time CT not released) · Presenter: Corey Miller, MD, MSc (Jewish General Hospital / McGill University, Montreal) · Embargo: abstract published on ASCO site May 21, 2026, 5:00 PM ET

At a glance

  • Sponsor: Alpha Tau Medical Ltd. (Nasdaq: DRTS)
  • PI / presenter: Corey Miller, MD, MSc — Director of Therapeutic Endoscopy, Jewish General Hospital; Assistant Professor, McGill University
  • NCT ID: not specified in source materials (pooled across three studies)
  • Phase: Pooled analysis of three prospective phase 1/2 studies
  • Design: Integrated safety/efficacy analysis of EUS-guided intratumoral Alpha DaRT (Ra-224 diffusing alpha-emitter seeds); single-arm, multi-site (Jewish General Hospital and CHUM, Montreal, Canada; Hadassah Medical Center, Jerusalem, Israel)
  • N: 58 treated patients pooled across three studies
  • Primary endpoint(s): Safety; overall survival (efficacy)
  • Comparator: None (single-arm; benchmarked to historical chemotherapy OS)
  • Indication: Locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
  • Line: 2L and beyond (also chemo-naive subset)

Headline result

In a pooled analysis of 58 patients across three prospective phase 1/2 studies of EUS-guided intratumoral Alpha DaRT in advanced PDAC, median overall survival from enrollment was 11.2 months in 2L metastatic and 11.1 months in 2L locally advanced disease — versus historical second-line chemotherapy benchmarks of ~4–6 months (metastatic) and ~9 months (locally advanced). In heavily pretreated patients (≥2 prior lines), median OS reached 17.1 months in locally advanced and 11.3 months in metastatic disease; third-line OS was 7.9 months (metastatic) and 8.8 months (locally advanced); chemo-naive OS was 7.1 months in both. Treatment-associated adverse events occurred in 36% of subjects, grade ≥3 in 9%, with no treatment-related deaths and no chronic toxicity. (No HR or p-values reported; single-arm design.)

Mechanism / class

Alpha DaRT (Diffusing Alpha-emitter Radiation Therapy) is an intratumoral radiotherapy: interstitial seeds loaded with radium-224 release short-range alpha-emitting daughter atoms (radon-220, polonium-216, etc.) that diffuse a few millimeters through tumor tissue, delivering a high-LET, highly localized ablative dose while sparing surrounding normal tissue. Delivered here by endoscopic ultrasound (EUS) guidance for pancreatic lesions. Investigational; no regulatory approval to date. Other Alpha Tau programs include the IMPACT trial (US; Alpha DaRT + modified FOLFIRINOX, NCT06698458) and ACAPELLA (France; Alpha DaRT + capecitabine).

Practice-changing?

No — pending. Hypothesis-generating single-arm data with no randomized comparator; the OS signal versus historical controls is encouraging in a disease with very poor prognosis, and the favorable safety profile supports feasibility of the EUS-guided one-time intratumoral approach. Confirmatory controlled trials (IMPACT, ACAPELLA) are required before any practice change.

Sources

  • ASCO Meeting Library: abstract on ASCO Annual Meeting site (published May 21, 2026; specific URL/abstract # not in press materials)
  • Company / trade-press:
  • Alpha Tau press release (Jun 1, 2026), strong OS results: https://finance.yahoo.com/sectors/healthcare/articles/alpha-tau-announces-strong-overall-130000848.html
  • StockTitan coverage (Jun 1, 2026): https://www.stocktitan.net/news/DRTS/alpha-tau-announces-strong-overall-survival-results-from-alpha-da-rt-1xeuh6ky8cu8.html
  • CancerNetwork (related EUS-guided Alpha DaRT coverage): https://www.cancernetwork.com/view/how-effective-and-safe-is-eus-guided-alpha-dart-in-pancreatic-cancer-
  • Alpha Tau ASCO acceptance announcement (Apr 27, 2026): https://www.globenewswire.com/news-release/2026/04/27/3281701/0/en/Alpha-Tau-Announces-Presentation-of-Pancreatic-Cancer-Data-at-Upcoming-ASCO-Annual-Meeting-Showcasing-Combined-Results-from-Three-Alpha-DaRT-Pancreatic-Cancer-Studies.html