Table 1.

Comparison of baseline demographics and efficacy outcomes in patients with ND IDH1mut AML treated on the pivotal registrational trials of VIALE-A (pooled analysis) and AGILE

Efficacy-evaluable populationAZA with VEN N = 33IVO with AZA N = 72
Age, median (range or IQR) 76 (64-90) 76 (58-84) 
Response outcomes   
 Composite CR (CRc*) rate 67% 53% 
 CR rate 27% 47% 
Duration of response (mo)   
 Median time to CRc (range) 1.2 (0.8-8.1) 4.0 (1.7-8.6) 
 Median duration of CRc (95% CI) 21.9 (7.8-NE) NE (13.0-NE) 
Survival outcomes (mo or percentage)   
 Median OS (95% CI) 15.2 (7.0-NE) 24 (11.3-34.1) 
 Estimated 12-mo survival probability (95% CI) 57.6% (39.1-72.3) ~ 64% 
Efficacy-evaluable populationAZA with VEN N = 33IVO with AZA N = 72
Age, median (range or IQR) 76 (64-90) 76 (58-84) 
Response outcomes   
 Composite CR (CRc*) rate 67% 53% 
 CR rate 27% 47% 
Duration of response (mo)   
 Median time to CRc (range) 1.2 (0.8-8.1) 4.0 (1.7-8.6) 
 Median duration of CRc (95% CI) 21.9 (7.8-NE) NE (13.0-NE) 
Survival outcomes (mo or percentage)   
 Median OS (95% CI) 15.2 (7.0-NE) 24 (11.3-34.1) 
 Estimated 12-mo survival probability (95% CI) 57.6% (39.1-72.3) ~ 64% 

IQR, interquartile range.

*

Here defined as CR plus CRi in VIALE-A (pooled analysis) and CR/CRh in AGILE. CR plus CRi in AGILE was 54%.

Data derived from Pollyea et al11  and Montesinos et al.

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