Benzinga | Jun 16, 2021 08:02AM EDT

Aprea Therapeutics Announces Phase 1/2 Trial Of Eprenetapopt + Venetoclax + Azacitidine In TP53 Mutant AML Met Complete Remission Primary Efficacy Endpoint

* 37% CR rate in 30 efficacy-evaluable patients

BOSTON, June 16, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the Phase 1/2 trial evaluating the frontline treatment of eprenetapopt with venetoclax and azacitidine in patients with TP53 mutant AML has met the pre-specified primary efficacy endpoint of complete remission (CR) rate.

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 (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.

"We are pleased with these results from the combination of eprenetapopt with venetoclax and azacitidine in this very difficult-to-treat TP53 mutant AML population, a patient group with significant unmet medical need," said Eyal Attar, M.D., Chief Medical Officer of Aprea Therapeutics. "These data, which follow the recent granting of Fast Track and Orphan Drug designations by FDA, provide further demonstration of the potential for eprenetapopt in the treatment of myeloid malignancies. We continue to make excellent progress across our myeloid malignancies program and look forward to providing an update in July 2021 on our Phase 2 trial evaluating eprenetapopt with azacitidine as maintenance therapy in TP53 mutant MDS and AML patients who have received allogeneic stem cell transplant."