The company announced results at the 2019 ASh Annual Meeting for its French Phase 1b/2 clinical trial of APR-246.

Aprea Therapeutics (NASDAQ:APRE) has announced preliminary results of its French Phase 1b/2 clinical trial of APR-246 in mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

As quoted in the press release:

The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of patients with TP53 mutated MDS and AML. The clinical trial is sponsored by the Groupe Francophone des Myélodysplasies.

As of the data cutoff, the overall response rate (ORR) in 24 evaluable MDS patients was 74%, with a 66% complete remission (CR) rate, based on International Working Group criteria. With a median duration of follow-up of 6.4 months, the median overall survival (OS) for all enrolled patients (n=53) had not been reached. In addition, all responding patients were alive at data cutoff. Relative to baseline, mutant TP53 variant allele frequency (VAF) was significantly decreased in responding patients and undetectable in all patients who achieved a CR.

About the Clinical Trial

Eligible patients in the Phase Ib/II clinical trial include HMA naïve, TP53 mutated MDS and acute myeloid leukemia (AML). All enrolled patients were to receive APR-246 as a 4,500 mg fixed dose IV daily (days 1-4) and AZA over 7 days (days 4-10 or 4-5 and 8-12) in 28-day cycles. The primary endpoint of the trial is CR rate.

Click here to read the full press release.

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