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Perhaps the most compelling data regarding the synergy of APR-246 and azacitidine originates from the clinical activity in TP53 mutant MDS/AML patients, where recent data report an overall and complete remission rate of 87% and 53%, respectively ( clinicaltrials.gov identifier: NCT03072043 ).9 Similarly, preliminary results from a phase II study of APR-246 and azacitidine by the Groupe Francophone des Myélodysplasies ( clinicaltrials.gov identifier: NCT03588078 ) showed comparable response rates.10 Accordingly, the US Food and Drug Administration has recently granted breakthrough therapy designation for the treatment of patients with TP53 mutant MDS with the combination of APR-246 and azacitidine and the randomized phase III study of APR-246 and azacitidine versus azacitidine is ongoing in MDS patients ( clinicaltrials.gov identifier: NCT03745716 )
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Other limitations include the fact that the in vitro granuloma model used is not an exact replication of in vivo granulomas which have a more complex and dynamic environment containing other cells like fibroblasts, collagen matrix, and other white blood cells