Table 1:
Demographics of Patients in the Pivotal cohort of Study 2102-HEM-101
| Disease Characteristics | Olutasidenib 150mg BID (N=147) |
|---|---|
| Median Age (range) | 71 (32–87) |
| Age Categories (years) | |
| <65 | 37 (25) |
| 65–74 | 65 (44) |
| >75 | 45 (31) |
| Sex at Birth | |
| Female | 73 (50) |
| Male | 74 (50) |
| Race, n (%) | |
| White | 67 (46) |
| Asian | 5 (3) |
| Black | 5 (3) |
| Other/Not Reported | 70 (48) |
| Baseline ECOG | |
| 0 | 45 (31) |
| 1 | 76 (52) |
| 2 | 23 (16) |
| Type of AML | |
| Primary | 97 (66) |
| Secondary | 50 (34) |
| Relapsed/Refractory Category | |
| Primary Refractory | 46 (31) |
| Refractory Relapse | 20 (14) |
| Untreated Relapse | 81 (55) |
| Cytogenetics | |
| Favorable | 6 (4) |
| Intermediate | 107 (73) |
| Poor | 25 (17) |
| Unknown | 9 (6) |
| IDH1 Mutation Type | |
| R132C | 85 (58) |
| R132H | 35 (24) |
| R132G | 12 (8) |
| R132S | 11 (7) |
| R132L | 4 (3) |
| Prior Stem Cell Transplant | 17 (12) |
| Transfusion Dependent at Baseline | 86 (59) |
| Median Number of Prior Therapies (Min, Max) | 2 (1,7) |
Source: FDA Data