Alpha Tau Announces Publication in Cancers Journal of Long-Term Safety and Efficacy Data in Multiple Hard-to-Treat Superficial Cancers

The pooled analysis included data from 4 international clinical trials spanning an array of hard-to-treat indications including skin, head & neck, and oral cavity.

Initial response data demonstrated an overall response rate of almost 100% in treated lesions and a complete response rate of 89%.

With follow–up as long as 51 months (median follow–up of 14-months), no moderate or severe long-term toxicities were noted, and 2-year local recurrence–free survival was estimated at 77%.

JERUSALEM, June 25, 2024 (GLOBE NEWSWIRE) — Alpha Tau Medical Ltd. (“Alpha Tau”, or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT™, announced today the publication of an article entitled “Extended Follow-Up Outcomes from Pooled Prospective Studies Evaluating Efficacy of Interstitial Alpha Radionuclide Treatment for Skin and Head and Neck Cancers” in the journal Cancers, with further detail on data previously announced by the Company in August 2023. The publication was authored by clinical investigators from Israel, Italy and the United States.

The aim of the analysis was to evaluate the long-term toxicity outcomes and disease control rates for patients treated with Alpha DaRT and followed for up to four years. In this pooled analysis of 81 treated head and neck, oral cavity and skin tumors from four clinical trials with a median follow-up of 14 months (range of 2—51 months), the overall response rate was 99%, with a complete response observed in 89% of treated lesions, a 10% partial response rate, and one patient non-evaluable. Two-year local recurrence-free survival was 77%, and there were no grade 2 or higher late toxicities observed. Clinical variables, including recurrent versus non-recurrent lesions, baseline tumor size, or histology, did not impact long-term outcomes.

The published results indicate that the Alpha DaRT treatment may provide tumor control even beyond the acute treatment period of short-term local responses, potentially leading to longer-term disease control. The lack of moderate or severe toxicities observed in this analysis is promising and suggests that Alpha DaRT may potentially offer an appropriate long-term treatment for these very difficult-to-treat cancers. Further follow-up and additional clinical studies are ongoing and will provide additional characterization of the safety and efficacy profile of Alpha DaRT.

Alpha Tau CEO Uzi Sofer stated, “We are encouraged by the perspective offered by this long-term data and its publication in a renowned journal such as Cancers. The publication of this comprehensive pooled analysis reinforces our belief in the sustained benefit of Alpha DaRT for patients with hard-to-treat cancers who have limited treatment options. We have additional ongoing studies in multiple tumor types and this long-term safety and efficacy snapshot shows great promise for the future when fighting the most difficult cancers. We are now poised for our next breakthrough and will continue working hard making excellent progress in our exciting clinical pipeline.”

Dr. Robert Den, M.D., Alpha Tau CMO, commented, “The publication of this long-term analysis is extremely gratifying. After years of research, the combined picture shows great clinical promise with no moderate or severe long-term toxicity. Now that we have a published study with a range of up to 51 months with strong durability and a favorable safety profile, we are hopeful this will provide a new therapeutic pathway for patients who have few options. In addition, we are looking forward to results from several ongoing and planned clinical trials in pancreas, brain, vulva, lung and liver metastases.”

Prof. Aron Popovtzer M.D., Head of the Sharett Institute of Oncology at Hadassah Medical Center in Jerusalem, and lead author of the publication, commented, “This analysis presents in fully published form, for the first time, an enhanced clinical picture of the potential benefit that Alpha DaRT may provide to patients with these hard-to-treat skin, head and neck cancers. The long-term analysis of safety and efficacy compares very favorably to other radiotherapeutic studies using external beam radiation, but with a much lower incidence of complications. We are excited and hopeful about the future potential of Alpha DaRT in the treatment of various solid tumors and in combination with systemic therapies such as immunotherapy and chemotherapy.”