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Efficacy Results in Patients with IDH1-Mutated R/R AML on Study 2102-HEM-101
| Endpoint | Olutasidenib (150mg BID), N=147 |
|---|---|
| CR + CRh, n (%) | 51 (35) |
| 95% CI | (27,43) |
| Median DOCR + CRh (months) | 25.9 |
| 95% CI | (13.5, NR) |
| CR, n (%) | 47 (32) |
| 95% CI | (25,40) |
| Median DOCR (months) | 28.1 |
| 95% CI | (13.8, NR) |
| CRh, n (%) | 4 (2.7) |
| 95% CI | (4.5,13.1) |
| Median DOCRh (months) | 3.6 |
| 95% CI | (1,5.5) |
| Conversion from TD to TI, n (%) | 29/86 (34%) |
| Maintenance of TI, n (%) | 39/61 (64%) |
Source: FDA Data
