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About 20% of patients with TP53 mutant bone marrow growth abnormal syndrome (MDS) receive complete remission (CR) after treatment with demthylation drugs.
Eprenetapopt (APR-246) is a new, class of small molecules that can restore the function of wild p53 in TP53 mutant cells.
study is an Ib/II study designed to clarify the safety, recommended Phase II dose and efficacy of Eprenetapopt in the treatment of patients with TP53 mutant MDS or acute myeloid leukemia (AML).
55 patients (40 MDS, 11 AML, 4 MDS/bone marrow proliferating tumors) were recruited for the TP53 mutation frequency in patients with or without remission, all carrying at least one TP53 mutation.
71% of patients, 44% of whom received complete remission (CR).
in MDS patients, 73% (29) of patients received remission, 50% (20) received CR, and 58% (23/40) received cytogenetic remission.
AML patients had a total remission of 64% (7 bits) and a CR rate of 36% (4 bits).
the CR rate was higher in patients with only TP53 mutations (second-generation sequencing) (69% vs. 25% ;p 0.006).
results showed that the frequency of TP53 variation and p53 expression were significantly reduced in the relieved patients, of which 21 cases (38%) received complete molecular remission (variant allied gene frequency of 5%).
the overall medium survival of patients with or without remission was 10.8 months, and the total survival of patients who received remission was significantly longer (14.6 vs. 7.5 months; p-0.0005) compared to patients who were not remissioned.
19 (35%) of the 55 patients received allogeneic hematopoietic stem cell transplants, with a total survival of 14.7 months.
adverse reactions were similar to previously reported monotherapies of azatide or Eprenetapopt, with the most common ≥stration 3 adverse reactions being febrile negatocyte reduction (33%), leucinocytosis (29%) and negatocyte reduction (29%).
the same time, Eprenetapopt combined with Aza cytosine therapy TP53 mutant MDS and oligocytocyte AML has good tolerance, and the clinical and molecular remission rates are high.
