- 88% ORR, 61% CR rate by IWG criteria in 33 evaluable MDS patients
- 8.4 months median duration of response, with 7.3 months median duration of CR in evaluable MDS patients
- 52% of evaluable MDS patients discontinued treatment for stem cell transplant
Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, presented results at the 2019 ASH Annual Meeting from its U.S. Phase Ib/II clinical trial in MDS and AML. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of TP53 mutated MDS and AML. The clinical trial is sponsored by the Moffitt Cancer Center with financial support from the MDS Foundation and the Aplastic Anemia and MDS International Foundation as administrator for the Evans MDS Clinical Research Consortium.
As of the data cutoff, the overall response rate (ORR) in 33 evaluable MDS patients was 88%, with a 61% complete remission (CR) rate, by International Working Group (IWG) criteria. With a median duration of follow-up of 10.8 months, the median duration of response was 8.4 months and the median duration of CR was 7.3 months. Seventeen (52%) evaluable MDS patients discontinued therapy to pursue stem cell transplant. Median overall survival (OS) for all enrolled patients (n=55) was 10.8 months. Median OS in responding patients versus non-responders was 13.7 vs. 3.9 months. Adverse events, regardless of causality, were mostly grade 1/2. Grade 3+ adverse events occurring in ≥20% of patients were limited to cytopenias and infection, consistent with underlying hematopoietic malignancies, and no exacerbation of the expected AZA-related safety profile has been observed.
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