SELLAS Life Sciences Group IncSLS announced updates relating to its ongoing Phase 3 REGAL study for galinpepimut-S (GPS) in acute myeloid leukemia (AML) patients who have achieved complete remission following second-line salvage therapy (CR2 patients).
A review of preliminary data suggests that the median overall survival (OS) in the pooled study population is likely considerably longer, by approximately two-fold, than initially anticipated and upon which the statistical analysis plan was based.
The overall duration of the REGAL study is now expected to be longer than initially predicted.
SELLAS is implementing changes to the SAP and protocol for the REGAL study as follows:
The total targeted enrollment in the study will increase from 116 to 125 – 140 patients.
The targeted number of events (deaths) for the interim analysis will be reduced to 60 from 80 and is currently expected to occur in late 2023 or early 2024.
The targeted number of events (deaths) for the final analysis will be reduced to 80 from 105 and is currently expected to occur by the end of 2024.
Statistical significance would be achieved by an estimated hazard ratio (HR) for OS of 0.636, corresponding to an OS of 12.6 months versus eight months for GPS versus BAT, respectively.
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