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A Phase III study of patients with TP53 mutant bone marrow growth syndrome has failed to reach the primary endpoint of its total remission (CR) rate, pharmaceutical company Aprea Therapeutics said recently.
the company said that although the CR rate was 53 percent higher in patients in the eprenetapoption group than in patients in the Azat group, the difference was not significant.
Attar, chief medical officer of Aprea Therapeutics, said: "We continue to believe that eprenetapopt can provide clinical benefits for patients with TP53 mutant malignancies.
the small molecule drug to treat TP53 mutant bone marrow growth abnormal syndrome and TP53 mutant acute myeloid leukemia won the FDA breakthrough therapy title."
the trial recruited 154 patients with TP53 mutant bone marrow growth abnormal syndrome who were randomly assigned to receive the separate use of azatsin or aza cytosine combined with eprenetapopt.
results showed that the CR rate of the eprenetapopt group was 33.3%, compared with 22.4% in the Aza cytosine group.
the company noted that the total survival of the middle is similar between treatment groups.
but the eprenetapopt joint Aza cytosine group showed good tolerance, and the adverse event characteristics were similar to those of the Phase II trial.
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