Comparison of baseline demographics and efficacy outcomes in patients with IDH2mut AML treated on the VIALE-A (pooled analysis), AG221-AML-005, and ENA (registrational trial)
| Efficacy-evaluable population . | AZA with VEN N = 50 . | ENA with AZA N = 68 . | ENA N = 109 . |
|---|---|---|---|
| Age, median (range or IQR) | 76 (64-90) | 75 (70-79) | 67 (19-100) |
| Trial design and setting | Phase 3, ND | Phase 1b/2, ND | Phase 1/2, relapsed/refractory |
| Response outcomes | |||
| Composite CR (CRc*) rate | 86% | 57% | 26.8% |
| CR rate | 56% | 54% | 20.2% |
| Duration of response (mo) | |||
| Median time to CRc (range or IQR) | 1.1 (0.7-8.8) | 4.6 (2.3-6.7) | 3.7 (0.7-11.2) |
| Median duration of CRc (95% CI) | NE (16.7-NE) | NE (10.2-NE) | 8.8 (0.7-11.2) |
| Survival outcomes (mo or percentage) | |||
| Median OS (95% CI) | NE (17.6-NE) | 22.0 (14.6-NE) | 9.3 (8.2-10.9) |
| Estimated 12-mo survival probability (95% CI) | 75.6% (61-85.3) | 72% (60-82) | 39% |
| Efficacy-evaluable population . | AZA with VEN N = 50 . | ENA with AZA N = 68 . | ENA N = 109 . |
|---|---|---|---|
| Age, median (range or IQR) | 76 (64-90) | 75 (70-79) | 67 (19-100) |
| Trial design and setting | Phase 3, ND | Phase 1b/2, ND | Phase 1/2, relapsed/refractory |
| Response outcomes | |||
| Composite CR (CRc*) rate | 86% | 57% | 26.8% |
| CR rate | 56% | 54% | 20.2% |
| Duration of response (mo) | |||
| Median time to CRc (range or IQR) | 1.1 (0.7-8.8) | 4.6 (2.3-6.7) | 3.7 (0.7-11.2) |
| Median duration of CRc (95% CI) | NE (16.7-NE) | NE (10.2-NE) | 8.8 (0.7-11.2) |
| Survival outcomes (mo or percentage) | |||
| Median OS (95% CI) | NE (17.6-NE) | 22.0 (14.6-NE) | 9.3 (8.2-10.9) |
| Estimated 12-mo survival probability (95% CI) | 75.6% (61-85.3) | 72% (60-82) | 39% |
IQR, interquartile range.
Here defined as CR plus CRi in VIALE-A (pooled analysis) and enasidenib and CR plus CRh in AG221-AML-005. CR plus CRi in AG221-AML-005 was 63%.
Data derived from Pollyea et al11 ; DiNardo et al21 ; and Stein et al.20