Alpha Tau Reports Positive Data Demonstrating 100% Objective Response Rate and 18.2-Month Median Overall Survival with Alpha DaRT in Combination with Pembrolizumab in Locally Advanced or Metastatic Head and Neck Cancer, Surpassing the Study's Pre-Specified Threshold for Success
The ORR and DCR rates were 12.5% and 56.3% respectively; 6 had partial response, 21 had stable disease, and 21 had progressive disease.
A single‑center, prospective, open‑label, single‑arm study of Alpha DaRT combined with pembrolizumab in elderly patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) reported that 9 evaluable patients achieved a 100 % systemic objective response rate (40 % complete, 55 % partial), a median overall survival of 18.2 months, and a median progression‑free survival of 5.4 months. No Alpha‑DaRT‑associated serious adverse events were observed, and only two grade 1 Alpha‑DaRT events were reported.
These data suggest that adding localized alpha‑radiation (Alpha DaRT) to systemic checkpoint inhibition can dramatically increase response rates and survival in an elderly population that often cannot tolerate chemotherapy, potentially expanding therapeutic options for patients with advanced head and neck squamous cell carcinoma.
Bizonyítékszint: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
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