Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 128

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 128
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and cSCC is the most common skin cancer seen in this population, with a 65 - 100 fold greater incidence in organ transplant recipients
compared to the general population. In addition, a 2003 article in the New England Journal of Medicinecited a number of sources
indicating that 50% or more of Caucasian transplant recipients will ultimately develop cutaneous carcinomas.

The primary efficacy endpoint
of the study is the ORR to the treatment, as measured by best overall response. Secondary efficacy endpoints include progression-free
survival, overall survival and local control up to twelve months after treatment, and the safety objective is the measurement of any related
AEs.

France multi-center - skin cancer
(recruiting)

We have initiated a multi-center
study at up to six cancer centers in France to investigate the safety and efficacy of Alpha DaRT for the treatment of malignant cutaneous
tumors. The target population will consist of two cohorts: newly diagnosed patients (up to 49 subjects), and patients with recurrent disease
or aggressive pathology (i. e., melanoma) (36 subjects). The primary effectiveness endpoint is the assessment of the ORR using Response
Evaluation Criteria in Solid Tumors criteria, or RECIST, 9 to 11 weeks after Alpha DaRT source insertion. The secondary effectiveness
endpoints include assessment of the reduction in tumor volume based on CT / ultrasound / physical examination-measured tumor volume at
9 to 11 weeks, assessment of Alpha DaRT source placement using CT imaging on the day of Alpha DaRT insertion, patient-reported health-related
QoL outcomes, and Disease-Free Survival at 12- and 24-months post-Alpha DaRT source insertion. Safety objectives include assessment of
acute AEs both related and unrelated to Alpha DaRT administration, according to Common Terminology Criteria for Adverse Events, or CTCAE,
version 5.0, all vital signs, blood and urine tests, and subject external radiation levels, and assessment of chronic AEs related to Alpha
DaRT at 12- and 24-months post-source insertion. The first patient was treated in this trial in June 2022.

Long-term safety and efficacy data

In August 2023, we released
long-term safety and efficacy data that were collected from patients treated with Alpha DaRT across four feasibility trials of head and
neck or skin cancers conducted at six institutions across the world. These data were then published in a journal article in June 202