- SELLAS Life Sciences Group Inc SLS 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.
- Related: SELLAS Life Sciences' GPS Combo Therapy Shows Overall Survival Of 18 Months In Pretreated Ovarian Cancer Patients.
- 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.
- As of September 30, 2022, cash and cash equivalents totaled approximately $21.3 million.
- Price Action: SLS shares are down 42.30% at $2.63 on the last check Monday.
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