. 2020 Jan 24;8(1):13–32. doi: 10.1007/s40487-019-00108-x

Table 2.

Completed AML clinical trials with ivosidenib

Study	Phase	Population	Association	Results (efficacy)	Results (safety)	Reference	Status
Ivosidenib
NCT03245424	II	R/R AML	–	ORR 41%, cCr 30%, CR 22%, OS 8.8 months	QTc pr. 7% G > 3 IDH-DS 4.7% G > 3	[93]	Completed

Study

Phase

Population

Association

Results (efficacy)

Results (safety)

Reference

Status

Ivosidenib

R/R AML

–

ORR 41%, cCr 30%,

CR 22%, OS 8.8 months

QTc pr. 7% G > 3 IDH-DS 4.7% G > 3

Completed

Mechanism: inhibition of IDH1-mutant enzyme

Status: approved by FDA as a single agent in R/R AML patients with proven IDH1 mutation (July 20, 2018)

CR complete response, OS overall survival