Alpha Tau Medical Ltd. announced initial long-term safety and tumor control outcomes for patients with unresectable, recurrent, or locally advanced head and neck or skin tumors treated Alpha DaRT across four prospective trials conducted at several international institutions. Between February 2017 and December 2022, 81 lesions in 71 patients were treated with Alpha DaRT in four prospective feasibility trials whose objective was to assess early toxicity and tumor response outcomes. The median follow-up was 14 months (range: 2-51 months).

A complete response (CR) was observed in 89% of treated lesions (n=72), 10% (n=8) demonstrated a partial response, and one patient was not evaluable. The two-year actuarial local recurrence-free survival (LRFS) was 77% [95% CI: 63?87]. Variables including recurrent vs non-recurrent lesions, baseline tumor size, or histology did not impact long-term outcomes.

20% of patients developed treatment-related acute grade 2 toxicity (such as dermatitis radiation, local pain at the treatment site or pruritus), which subsequently resolved with conservative treatment; there were no grade 3 or higher related acute toxicities. There was no grade 2 or higher late toxicities observed in this cohort, defined as toxicities occurring six months or later after Alpha DaRT treatment.