Alpha Tau Reports 100% ORR and 18.2-Month OS in Head and Neck Cancer Combo Trial
DRTS has more than doubled off its 52-week low of $2.87.
Summary
Alpha Tau announced positive data from a study of Alpha DaRT combined with Keytruda in head and neck cancer, showing a 100% response rate and 18.2-month median survival, surpassing the trial's success threshold.
Key Events · Product Development and Regulatory · DRTS
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100% Objective Response Rate Achieved
All nine evaluable patients responded to Alpha DaRT plus pembrolizumab, including four complete responses and five partial responses, versus a 19% ORR for pembrolizumab monotherapy in KEYNOTE-048.
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Median Overall Survival of 18.2 Months
Median OS reached 18.2 months, compared to 12.3 months for pembrolizumab alone, with four patients still alive at analysis.
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Trial Met Pre-Specified Success Criterion
The Simon two-stage adaptive design required more than six responders to stop for success; with nine responders, enrollment is now complete.
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Favorable Safety Profile
No Alpha DaRT-related serious adverse events; only two Grade 1 (mild) adverse events reported.
Analysis · DRTS · Industrial Applications And Services
In elderly HNSCC patients, the combination of Alpha DaRT and pembrolizumab delivered a 100% objective response rate and 18.2-month median overall survival—far surpassing the 19% ORR and 12.3-month OS seen with pembrolizumab alone. The trial met its pre-specified success threshold, and enrollment is now complete. These results validate the combination strategy and strengthen the case for larger registrational studies, potentially transforming the treatment landscape for this difficult-to-treat population.
At the time of this filing, DRTS was trading at $13.54 on NASDAQ in the Industrial Applications And Services sector, with a market capitalization of approximately $1.2B. The 52-week trading range was $2.87 to $14.11. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.