Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 132

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 132
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 definitely associated with Alpha
DaRT treatment, of which three were deemed SAEs.

An analysis of best overall
response in patients with a measured response indicated an 18% objective response rate and 91% disease control rate, or 19% and 97%,
respectively, when excluding the first two patients, who were deliberately given low dosages in order to determine feasibility and safety
only. An analysis using Kaplan-Meier statistics indicated median o verall
survival across the 33 patients of 18.6 months from diagnosis or initiation of the previous round of chemotherapy, or 10.9 months from
treatment with Alpha DaRT. In addition, ad-hoc analyses of pancreatic cancer population subgroups suggested meaningful improvement in
median overall survival from diagnosis or initiation of the previous round of chemotherapy across all analyzed subgroups, for patients
treated with Alpha DaRT after prior therapy, compared to previously published studies of alternative monotherapies, though caution should
be exercised in comparing results from unrelated clinical studies due to differences in study designs, patient populations and other
relevant factors.

Specifically,
as of January 8, 2025:

  For                                                                                             

  For                                                                                             

  For                                                                                              

U. S. Pilot Study (planning)

Following the approval
of an IDE by the FDA, we are currently working to initiate a clinical study in the U. S. to evaluate the safety of Alpha DaRT with
chemotherapy for the treatment of locally advanced and metastatic pancreatic cancer. The IDE allows us to recruit up to 30 patients
at up to 10 U. S. institutions, in two cohorts: (1) 15 patients with newly diagnosed locally advanced inoperable pancreatic cancer,
and (2) 15 patients with newly diagnosed metastatic pancreatic cancer. Patients will begin modified FOLFIRINOX chemotherapy and will
undergo Alpha DaRT treatment during the first four cycles of chemotherapy.

The primary objective of the
study will be to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity
and outcome of treatment-emergent AEs, which will be classified according to CTCAE version 5.0. Secondary objectives will include the
assessment of efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival,
pain control, and the rate of surgical resection in the cohort with locally advanced pancreatic cancer.

The primary endpoint of the
study will