Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 140

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 140
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 pembrolizumab, a humanized antibody targeting
the PD-1 receptor of lymphocytes, and Alpha DaRT have shown positive results in clinical studies in the treatment of HNSCC. Consequently,
we are aiming to explore the combination of these interventions as a potential treatment for metastatic or recurrent HNSCC.

Study objectives and design

The primary objectives of
this study are to evaluate efficacy of Alpha DaRT in combination with pembrolizumab via the Confirmed BOR as defined by RECIST. Secondary
objectives include assessments of the frequency, severity and causality of acute adverse events related to the Alpha DaRT treatment in
combination with pembrolizumab. Patients enrolled in the trial will receive pembrolizumab cycles every three weeks both before and after
receiving Alpha DaRT treatment. The study uses a two-stage adaptive design and can recruit up to 48 patients, with a planned interim analysis
after the first 18 patients have been treated. Adverse events will be assessed and graded according to CTCAE version 5.0. PFS will be
defined as the time from pembrolizumab treatment start date to progressive disease according to RECIST or death due to any cause, whichever
occurs first. OS is defined as the time from pembrolizumab treatment start date to death due to any cause or lost to follow up. DOR is
defined as the interval from the time measurement criteria are first met for CR, PR, or stable disease (whichever is first recorded) until
the first date recurrent or progressive disease is objectively documented. Exploratory objectives include the assessment of immunological
parameters as a result of Alpha DaRT administration in combination with pembrolizumab. The image below illustrates the trial design for
this combination study:

Interim Results

In January 2025, we announced
interim data from this study. As of January 9, 2025, eight patients were enrolled for treatment with Alpha DaRT and pembrolizumab in the
study. Of the eight patients treated, three demonstrated a systemic complete response, three demonstrated a systemic partial response,
and two patients died before being evaluated, demonstrating a 37.5% systemic complete response rate and a 75% systemic objective response
rate. In addition, no SAEs related to Alpha DaRT treatment were reported in these patients as of the data cutoff date of January 9, 2025.

In addition to the trial described