Aprea : Phase 1/2 Trial On TP53 Mutant AML Meets Complete Remission Primary Efficacy Endpoint

Aprea Therapeutics Inc. (APRE) said that the phase 1/2 trial, which evaluated the frontline treatment of eprenetapopt with venetoclax and azacitidine in patients with TP53 mutant acute myeloid leukemia or AML, has met the pre-specified primary efficacy endpoint of complete remission or CR rate.

In Wednesday pre-market, APRE was trading at $6.88 up $2.03 or 41.86%.

In 30 patients who were evaluable for efficacy at the time of the analysis, the CR rate was 37% and the composite response rate of CR plus CR with incomplete hematologic recovery or CRi, CR/CRi, was 53%.

The trial met the primary efficacy endpoint of CR, which is based on a Simon 2-stage design. As of the data cut, 11 patients remain on study treatment and continue to be followed for safety and efficacy.

The company plans to discuss the dataset with the U.S. Food and Drug Agency (FDA) in the second half of 2021 and expects to present data from the trial at a future scientific or medical conference.

The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. The mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.

Acute myeloid leukemia is the most common form of adult leukemia, with the highest incidence in patients aged 60 years and older. AML is characterized by proliferation of abnormal immature white blood cells that impairs production of normal blood cells.

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