- Aprea Therapeutics Inc APRE has announced that the Phase 1/2 trial evaluating eprenetapopt in acute myeloid leukemia (AML) has met the pre-specified primary efficacy endpoint of complete remission (CR) rate.
- The trial is assessing eprenetapopt with venetoclax and azacitidine in patients with TP53 mutant AML.
- In 30 patients who were evaluable for efficacy at the time of the analysis, the CR rate was 37%.
- The composite rate of CR plus CR with incomplete hematologic recovery (CRi), CR/CRi, was 53%.
- Eleven patients remain on study treatment and continue to be followed for safety and efficacy as of the data cut.
- The Company plans to discuss the dataset with the FDA in the second half of 2021.
- Data from the trial will be presented at a future scientific or medical conference.
- Price Action: APRE shares are up 49.7% at $7.26 during the premarket session on the last check Wednesday.
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