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DRTS-News
DRTS-Events
Alpha Tau Receives FDA Approval to Expand REGAIN Trial to 20 Patients
Alpha Tau announced that the FDA has approved an investigational device exemption, or IDE, supplement expanding its U.S. REGAIN trial. The company also announced that an abstract has been accepted for presentation at the 31st Annual Meeting of the Society for Neuro-Oncology, or SNO, to be held November 12-15. Under the approved supplement, REGAIN can now enroll up to 20 patients, up from the previously approved 10 patients, at the three U.S. academic cancer centers authorized to participate. Based on initial discussions, the Company believes that the expanded trial could generate additional data on the use of Alpha DaRT to treat recurrent glioblastoma, which may support market submission requirements for Alpha DaRT in patients with this disease. The updated protocol also opens the study to patients with IDH-mutant grade 4 tumors, which the World Health Organization has classified separately from glioblastoma since 2021, adds progression-free survival as a secondary endpoint; and introduces regular quality-of-life assessments. The protocol also provides for an additional interim analysis six months after the fifth patient's treatment, which occurred in July.
Alpha Tau Completes Patient Enrollment in IMPACT Study
Alpha Tau announced the completion of patient enrollment in its IMPACT study - a multicenter pilot study evaluating intratumoral Alpha DaRT in combination with first-line chemotherapy for patients with newly diagnosed, unresectable locally advanced or metastatic pancreatic adenocarcinoma. A total of 48 patients have been enrolled.
Alpha Tau Achieves Major Progress in Q2 2026
"The second quarter of 2026 was without question the busiest and most consequential period in Alpha Tau's history, and the momentum has only continued to accelerate since," said Alpha Tau CEO Uzi Sofer. "In the space of a few weeks we reported groundbreaking interim results in recurrent glioblastoma, completed enrollment in our first U.S. pivotal trial, presented compelling new pancreatic cancer survival data at both Digestive Disease Week and the ASCO Annual Meeting, and announced our first major U.S. commercial partnership. This Company continues to transform itself completely, from a single-asset clinical story into a broad, multi-indication platform with a partnered commercial pathway and a rapidly expanding global clinical footprint."
Alpha Tau Reports Clinical Study Results for Alpha DaRT
Alpha Tau announced results from a clinical study evaluating Alpha DaRT in combination with pembrolizumab in elderly patients with locally advanced and metastatic head and neck squamous cell carcinoma, or HNSCC, in which the combination produced a 100% objective response rate and a median overall survival of 18.2 months among evaluable patients. The results are being presented in a podium presentation at the American Head and Neck Society, or AHNS, 12th International Conference on Head and Neck Cancer, held July 18-22, in Boston, Massachusetts. Among evaluable patients, treatment with Alpha DaRT plus pembrolizumab produced an objective response rate of 100%, including four complete responses and five partial responses, for a complete response rate of 44%. By comparison, pembrolizumab monotherapy in the PD-L1 CPS greater than or equal to1 population of KEYNOTE-048 produced an objective response rate of approximately 19%. Median overall survival was 18.2 months, and median progression-free survival was 5.4 months, with four patients remaining alive at the time of this analysis. By comparison, pembrolizumab monotherapy in a similar population in the KEYNOTE-048 trial achieved a median overall survival of 12.3 months and a median progression-free survival of approximately 3.2 months. No Alpha DaRT-related serious adverse events were observed. Only two Alpha DaRT-related adverse events were reported across the treated cohort, both Grade 1 in severity.
Alpha Tau Medical Successfully Treats First Patient in ADMIRE Study
Alpha Tau Medical announced the successful treatment of the first patient in its ADMIRE study, a clinical trial evaluating intratumoral Alpha DaRT for immunocompromised patients with recurrent cutaneous squamous cell carcinoma, or cSCC. The ADMIRE study is designed specifically to evaluate whether Alpha DaRT can offer an alternative for this historically excluded and particularly vulnerable patient population. "This milestone matters to us for a reason that goes beyond any one patient," said Uzi Sofer, CEO of Alpha Tau. "There are many different reasons someone can become immunocompromised, but across nearly all of them, the same pattern holds: their cSCC comes back more often, and leaves them with far fewer treatment options than for others. This trial actually started with our physicians. Since we began enrolling ReSTART, our pivotal trial for recurrent cSCC, investigators at site after site have asked the same question on their own, right up to recently: could Alpha DaRT help their immunocompromised patients too, the ones ReSTART couldn't enroll? That's exactly the kind of trial our strategy is built around: treating patients whose tumors recur after surgery or radiation therapy, who are left with limited treatment options, and who need new solutions the most."
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