Alpha Tau Medical has completed patient enrolment in its ReSTART pivotal trial, assessing the efficacy and safety of its Alpha diffusing alpha-emitters radiation therapy (DaRT) for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC).
This marks Alpha Tau’s first pivotal clinical trial in the US to reach full enrolment. It is also regarded by the company as a substantial milestone towards Alpha DaRT’s potential pre-market approval (PMA) from the US Food and Drug Administration (FDA).
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The single-arm, open-label, multi-centre, pivotal trial is considered a critical clinical study that provides primary evidence for a medical product’s safety and efficacy, supporting regulatory decisions.
It transitions from recruitment to data follow-up and maturation, advancing Alpha Tau Medical’s progress toward a potential approval in the US.
The trial has enrolled 88 patients with biopsy-confirmed recurrent cSCC who have not responded to at least first-line standard therapy and lack further curative options.
The co-primary endpoints are objective response rate (ORR) based on confirmed best overall response, and duration of response (DOR) at six months from the initial response.
Secondary endpoints include progression-free survival and overall survival at one year, overall duration of response, local control, and quality of life.
The ReSTART trial builds on clinical studies of Alpha DaRT in Canada, France, Israel, Italy, and the US.
Alpha DaRT delivers concentrated intratumoral radiotherapy, aiming to serve patients with limited options. It already holds a breakthrough device designation from the FDA.
Alpha Tau Medical CEO Uzi Sofer said: “The completion of enrolment in the ReSTART pivotal trial is a watershed moment for Alpha Tau. Skin cancer was the very first clinical application of Alpha DaRT, and it has served as the cornerstone of our entire clinical development strategy.
“The years of evidence we have generated across multiple countries and numerous patients have consistently demonstrated the strength of our intratumoral radiotherapeutic approach – providing the foundation not only for this pivotal study, but also for our expanding clinical programmes in additional indications.”
In September 2024, the FDA granted approval for Alpha Tau Medical’s investigational device exemption (IDE) application to initiate a study of its Alpha DaRT therapy.
