Alpha DaRT Pembrolizumab Combo Shows 100% Response
Alpha Tau Medical announced positive results from a study of Alpha DaRT in combination with pembrolizumab for elderly patients with locally advanced or metastatic head and neck squamous cell carcinoma, presented at the AHNS International Conference. The nine evaluable patients achieved a 100% systemic objective response rate, with four complete responses and five partial responses, far exceeding historical pembrolizumab monotherapy benchmarks. Median overall survival reached 18.2 months and median progression-free survival was 5.4 months, again favorably compared with historical benchmarks. No serious Alpha DaRT-related adverse events were observed, with only two mild adverse events reported. The trial is a single-center, prospective, open-label, single-arm study using a Simon two-stage design, and recruitment has completed by meeting the predefined success criterion. These results bolster Alpha Tau’s strategy to pair Alpha DaRT with immunotherapy and support ongoing discussions with the FDA about future trials.
