On August 17, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported 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 (Press release, Alpha Tau Medical, AUG 17, 2023, View Source [SID1234634465]).
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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. Twenty percent 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.
"We are excited to share these longer-term data on outcomes from treatment with Alpha DaRT," noted Uzi Sofer, Alpha Tau’s CEO. "We have seen continued encouraging outcomes for patients treated with Alpha DaRT, with 89% complete response rate and no grade 3 or higher toxicities, demonstrating outstanding potential for patients." Dr. Robert Den, Alpha Tau’s CMO, added, "These data answer an important question for Alpha Tau, namely, whether the strong short-term local responses we’ve seen will lead to long-term tumor control. The answer is a resounding yes, with a 77% durable tumor control rate at 2 years. We are looking forward to continued generation of additional data from our clinical trials, including our U.S. pivotal multicenter ReSTART trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), our pancreatic cancer trial being conducted in Montreal, Canada, and other exciting trials underway or scheduled to launch soon."
Prof. Aron Popovtzer, Head of the Sharett Institute of Oncology at Hadassah Medical Center in Jerusalem, and a principal investigator in several of the trials, commented, "The ongoing and consistent strength of the results from treatment with Alpha DaRT speaks volumes about the transformative potential of Alpha DaRT for a broad array of patients with difficult-to-treat solid tumors."
About Alpha DaRT
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.