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Alpha Tau Announces Strong Overall Survival Results from Alpha DaRT Pancreatic Cancer Studies Presented at 2026 ASCO Annual Meeting - Results reinforce the potential feasibility and safety of Alpha DaRT as a one-time, mi

Key Takeaway: Alpha Tau Medical announced promising overall survival results for its Alpha DaRT treatment for pancreatic cancer, presented at the 2026 ASCO Annual Meeting. A pooled analysis from three Phase I/II studies showed significant median overall survival improvements in comparison to historical chemotherapy data. The treatment demonstrated a favorable safety profile with no chronic toxicity or treatment-related deaths reported. Following these results, Alpha Tau aims to continue its clinical trials for Alpha DaRT as a complementary therapy alongside front-line chemotherapy.

Market Sentiment Analysis

POSITIVE FACTORS

  • Strong overall survival results indicate the potential efficacy of Alpha DaRT.
  • The safety profile shows no treatment-related deaths and all Grade 3 events resolved.
  • Alpha DaRT demonstrated higher median overall survival compared to historical data for chemotherapy.
  • The treatment is intended as a minimally invasive option that fits naturally into patient care.

Full Press Release Details

Alpha Tau Announces Strong Overall Survival
Results from Alpha DaRT Pancreatic Cancer Studies Presented at 2026 ASCO Annual Meeting
- Results reinforce the potential feasibility
and safety of Alpha DaRT as a one-time, minimally invasive intratumoral treatment that fits naturally into the patient journey -
- Pooled analysis of three prospective Phase
I/II studies in locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) demonstrates encouraging median overall survival
(mOS) across chemotherapy-naive, second-line, and heavily pretreated patient populations -
-Patients treated with Alpha DaRT after 1st
line chemotherapy reached median overall survival (mOS) of 11.2 and 11.1 months in metastatic and locally advanced disease, respectively,
from the date of trial enrollment, compared to ~4 - 6 months for metastatic patients and ~ 9 months for locally advanced patients with
second-line chemotherapy, based on published historical data -
- Favorable safety profile observed across
the Alpha DaRT trials, with treatment-associated adverse events reported in 36% of subjects and Grade 3 events in 9%, with no treatment-related
deaths and no chronic toxicity; all Grade 3 events resolved -
- Following these strong survival data, Company
next turns to anticipated completion of recruitment in the multicenter U.S. IMPACT pancreatic cancer trial, which is exploring the ability
of Alpha DaRT, in combination with initiation of front-line chemotherapy, to deliver a potent and focused local dose without exacerbating
the harsh systemic side effects of standard chemotherapy -
Jerusalem, June 1, 2026 - Alpha Tau Medical
Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau", or the "Company"), the developer of the innovative alpha-radiation cancer
therapy Alpha DaRT , today announced positive overall survival and safety results from a pooled analysis of three prospective
Phase I/II clinical studies evaluating endoscopic ultrasound (EUS)-guided intratumoral Alpha DaRT treatment in patients with locally
advanced or metastatic pancreatic ductal adenocarcinoma (PDAC). The results were presented at the 2026 American Society of Clinical
Oncology (ASCO) Annual Meeting.
Pancreatic cancer remains one of the most lethal
of all solid tumors, with a five-year survival rate of less than 10% and survival often measured in only months for patients with advanced
disease. Treatment options are particularly limited for patients who are ineligible for chemotherapy or who have progressed through one
or more lines of systemic therapy, where historical survival is consistently poor and few effective interventions exist.
The pooled, ad-hoc analysis combined safety and
efficacy data from three studies, conducted at the Jewish General Hospital, at the Centre Hospitalier de l'Universit de Montr al
(CHUM) in Montreal, Canada, and at the Hadassah Medical Center in Jerusalem, Israel. The analysis included all patients who received the
intended Alpha DaRT treatment, with a range of patients having undergone varying lines of prior chemotherapy. Survival was analyzed using
the Kaplan-Meier method and assessed by disease stage (locally advanced versus metastatic) and by number of prior chemotherapy lines (zero,
Overall Survival Results
Note: Caution should be exercised in comparing
results from unrelated clinical studies due to differences in study designs, patient populations and other relevant factors.
Alpha DaRT-treated patients who had received
one prior line of chemotherapy achieved a median overall survival of 17.0 months in metastatic disease and 13.8 months in locally
advanced disease, from the date of initiation of the prior line of chemotherapy. Alpha DaRT as second-line therapy, measured from
study enrollment, achieved an mOS of 11.2 months in metastatic patients, while in the published literature, mOS for metastatic patients
with second-line chemotherapy is reported to be ~ 4-6 months (from initiation of second-line chemotherapy), and for the locally advanced
patients, achieved an mOS of 11.1 months, vs. ~9 months.
Alpha DaRT-treated patients who had received
two prior lines of chemotherapy - a heavily pretreated population for whom there is no established standard of care - achieved a median
overall survival of 17.1 months in locally advanced disease and 11.3 months in metastatic disease, from the date of initiation of
the second-line chemotherapy. Alpha DaRT as third-line therapy, measured from study enrollment, achieved an mOS of 7.9 months in metastatic
patients, and for the locally advanced patients, achieved an mOS of 8.8 months, while in the published literature, mOS for patients with
third-line chemotherapy is reported to be ~ 4-7 months (from the initiation of third-line chemotherapy).
Patients who were treated with Alpha DaRT and
who had not received any prior chemotherapy demonstrated mOS of 7.1 months from diagnosis in both locally advanced and metastatic diseases,
which includes mOS of 6.3 and 5.8 months, from trial enrollment, for locally advanced and metastatic patients, respectively.
Alpha DaRT was observed to have a favorable safety
profile. Treatment-associated adverse events were observed in 36% of subjects, and Grade 3 adverse events were observed in 9% of
subjects, including biliary obstruction, abdominal pain, fever, liver enzyme imbalance, and bacteremia. Importantly, there were no
treatment-related deaths, all Grade 3 adverse events resolved, and no chronic adverse events were observed. This
safety profile is especially relevant in advanced pancreatic cancer, where patients are often frail and where the cumulative toxicity
of ongoing systemic therapy can significantly compromise quality of life.
A key differentiator of Alpha DaRT is its potential
as a one-time, minimally invasive intratumoral administration, as compared to continuous oral or intravenous therapy.
Uzi Sofer, CEO of Alpha Tau, stated: "I have always
believed deeply in the potential of Alpha DaRT to be highly efficacious, but I say proudly that these results exceeded even my own
expectations, and are an outstanding extension of the interim results in these first-in-human trials that we observed last year. To
see this level of survival, achieved with a one-time treatment and without chronic side effects, in patients who today have so little
to turn to, strengthens our resolve to bring Alpha DaRT to as many of these patients as possible, as quickly as we responsibly can. These
first-in-human results are fantastic, and they demonstrate the potential of Alpha DaRT as a monotherapy, even when compared to standard-of-care
chemotherapies. And now we are even more excited about the treatment design of our U.S. IMPACT trial. In treating pancreatic cancer,
our goal is not to replace chemotherapy or other next-generation systemic therapies, our goal is to explore whether Alpha DaRT can serve
as a compelling focused local therapy and add a concurrent therapeutic boost without exacerbating the harsh systemic side effects of standard
chemotherapy regimens. We are excited about the advent of new systemic therapy options for pancreatic cancer patients, and given the safety
profile observed thus far for Alpha DaRT, we believe there is compelling rationale for exploring further combination trials in the future
with new systemic therapies as they become standard-of-care. Pancreatic cancer is one of the cruelest diagnoses, and these patients
deserve therapies that deliver not only meaningful efficacy, but also a safety profile and treatment experience that respect their quality
of life and fit into their journey rather than dominate it."
Corey Miller, MD, MSc, Director of
Therapeutic Endoscopy of the Division of Gastroenterology at the Jewish General Hospital, Assistant Professor of Medicine at McGill
University, and Principal Investigator in Canada, commented: "As the first physician in the world to deliver Alpha DaRT
into the pancreas using an endoscopic ultrasound-guided approach, seeing these results is genuinely extraordinary for me. I
treated some of the very first patients in this program, and that trajectory, from the early procedures all the way through to
receiving the survival outcome data with no observed chronic toxicity, has been truly fantastic to witness and a privilege to be a
Robert Den, MD, Chief Medical Officer of Alpha Tau, added: "These
pooled survival and safety data provide extremely encouraging reinforcement of our clinical strategy which we are moving decisively to
execute across a broad and increasingly global clinical program. Historically, local therapy has not played a big role in treating
non-resectable pancreatic cancer due to poor clinical trial results secondary to limitations on dose escalation in the pancreas in
light of the sensitive organs in the area, as well as the inability to dose chemotherapy at systemic therapy levels concurrently with
local therapy. We seek to make local therapy an integral part of the treatment of pancreatic cancer, without compromising the ability
to deliver systemic therapy concurrently. Our flagship multicenter IMPACT trial in the United States continues to advance, evaluating
Alpha DaRT in combination with chemotherapy in patients with newly diagnosed unresectable pancreatic cancer. The ACAPELLA trial in France,
evaluating Alpha DaRT alongside capecitabine in patients with locally advanced pancreatic cancer, is underway following the treatment
of its first patient. And our work at the prestigious University of Verona's Pancreas Institute is extending the program to include a
percutaneous delivery approach, broadening the range of patients who may be able to access this therapy. Together, these studies reflect
a deliberate, methodical effort to generate the rigorous evidence needed to bring Alpha DaRT to patients with one of the most significant
unmet needs in oncology."
The analysis presented is a pooled ad-hoc analysis
of three prospective Phase I/II clinical studies conducted at centers in Canada and Israel, evaluating EUS-guided intratumoral Alpha DaRT
in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma across varying lines of prior chemotherapy. The analysis
included all cases that received the intended treatment. Survival analyses used the Kaplan-Meier method, measured from the time of enrollment
or from the initiation of the previous line of chemotherapy, to death, and were analyzed by disease stage and number of prior chemotherapy
lines (zero, one, or two).
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

Frequently Asked Questions

What is Alpha DaRT's overall survival impact on pancreatic cancer?

Alpha DaRT shows promising median overall survival rates, achieving 11.2 months for metastatic patients and 11.1 months for locally advanced disease after first-line chemotherapy.

How safe is the Alpha DaRT treatment?

Alpha DaRT exhibits a favorable safety profile, with treatment-related adverse events in 36% of patients and no chronic toxicity or treatment-related deaths reported.

What stages of pancreatic cancer are treated with Alpha DaRT?

Alpha DaRT is applied in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have undergone various lines of prior chemotherapy.

How does Alpha DaRT compare to standard chemotherapy?

Alpha DaRT demonstrates improved overall survival compared to standard second-line chemotherapy, which typically offers 4-9 months of survival.

What is the future of Alpha DaRT in clinical trials?

The company is advancing the U.S. IMPACT trial, aiming to assess Alpha DaRT alongside front-line chemotherapy, focusing on local treatment without increasing systemic side effects.

Last updated: Jun 1, 2026