Response Rate

Among evaluable patients, treatment with Alpha DaRT plus pembrolizumab produced an objective response rate (i.e., systemic complete response plus partial response) 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 ≥1 population of KEYNOTE-048 produced an objective response rate of approximately 19%.

Survival Data

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.

Safety Results

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.