Mitchell, Just A Guy

Today at the AHNS International Conference on Head and Neck Cancer in Boston, $DRTS presented data that puts a number to what oncologists have theorized for years: what happens when you add localized, immune-activating alpha radiation directly inside a tumor to a first-line checkpoint inhibitor regimen. The KEYNOTE-048 trial set the benchmark: pembrolizumab as monotherapy produced a 19% objective response rate and 12.3 months median overall survival in PD-L1 positive recurrent or metastatic HNSCC. Alpha DaRT layered on top of that regimen, in nine evaluable elderly patients at Hadassah Medical Center, produced 100% objective response rate, a 44% complete response rate, and 18.2 months median overall survival. Progression-free survival reached 5.4 months versus 3.2 months for pembrolizumab alone. This study's interim data was first presented at an R&D Day in January 2025, when 75% ORR was observed in eight patients. The survival follow-up has now matured. The signal held and strengthened. Every evaluable patient responded, survival extended meaningfully beyond the pembrolizumab benchmark, and there were no Alpha DaRT-associated serious adverse events. The study hit its pre-specified success threshold, built into a Simon two-stage adaptive design, and enrollment was concluded on that basis. Watch for the FDA's response to the ongoing discussions Alpha Tau has initiated about a larger U.S. combination study. The design and patient population of that program will define where this clinical strategy goes next. globenewswire.com/news-relea… _ Disclosure: This content is not financial or investment advice. Alpha Tau Medical Ltd. is a paid subscriber to Wall Street Wire's coverage and distribution platform. Full disclosure: wallstwire.ai/disclosures