Aprea Therapeutics (NASDAQ:APRE) reported updated data from its Phase 1b/2 trial evaluating eprenetapopt, in combination with azacytidine, for the treatment of myelodysplastic syndromes (MDS) and acute myeloidleukemia (AML) with a susceptible tumor suppressor protein p53 (TP53) mutation.
At the April 1, 2020 data cutoff, the overall response rate in 28 evaluable MDS patients was 75%, with a complete remission rate of 57%. A median overall survival of 12.1 months was recorded for all 52 enrolled patients, as well as for the 34 MDS patients.
Those remaining on treatment for three or more cycles had a median overall survival of 13.7 months, compared with 2.8 months for patients who received fewer than three cycles of treatment.
“The data from this ongoing trial of eprenetapopt with azacitidine continue to be very encouraging in these most difficult-to-treat TP53 mutant MDS and AML patients, who not only have at least one TP53 mutation but the majority of whom also have high risk cytogenetic abnormalities,” Dr. Thomas Cluzeau, the study’s co-lead investigator, said in a statement.
“Furthermore, with increased duration of follow-up, we now also see the emergence of highly encouraging overall survival that appears to be better than azacitidine alone or in combination with others agents in this very high-risk molecular group of patients with a TP53 mutation,” he added.
