On December 13, 2021 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, reported updated results from its Phase 2 trial evaluating eprenetapopt with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML at the 2021 ASH (Free ASH Whitepaper) Annual Meeting (Press release, Aprea, DEC 13, 2021, View Source [SID1234596907]).

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In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 year post-transplant was 60% and the median RFS was 12.5 months. The overall survival (OS) at 1 year post-transplant was 79%, with a median OS of 20.6 months. Published studies evaluating post-transplant outcomes in TP53 mutant MDS and AML patients have reported a 1-year post-transplant RFS of ~30% and a median OS of ~5-8 months. In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial. Given the encouraging data, the Company intends to explore opportunities to conduct future randomized clinical trials to further assess safety and efficacy of this combination in the post-transplant maintenance setting.

"This update of data at ASH (Free ASH Whitepaper), representing the primary analysis, highlights the very encouraging outcomes for these TP53 mutant MDS and AML patients who received eprenetapopt and azacitidine as post-transplant maintenance therapy," said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute. "As these patients characteristically have poor outcomes, even with transplantation, this post-transplant maintenance regimen is potentially paradigm-shifting and I look forward to investigating it further."

Slides for this presentation can be accessed from "Presentations" in the News and Events section of the Company’s website at Link.