APR-246 & Azacitidine for the Treatment of TP53 Mutant Myelodysplastic Syndromes (MDS)

Summary

A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.

Timeline

Start

2019-01-11

Primary completion

2020-11-27

Completion

2022-01-14

Outcome

Missed primary endpoint

release “In December 2020, the Company announced that its pivotal Phase 3 trial failed to meet its predefined primary endpoint of complete remission (CR) rate.” aprea.com ↗

release “Phase 3 clinical trial of eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS has been completed and failed to meet the primary endpoint” aprea.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	APR-246	Small molecule	—	—
Subject	Azacitidine	Other / unclassified	—	—

Indications