Comparison of baseline demographics and efficacy outcomes in patients with IDH1mut R/R AML treated on the pivotal registrational trials of olutasidenib and ivosidenib
| Efficacy evaluable population . | Olutasidenib32 N = 147 . | Ivosidenib15 N = 125 . |
|---|---|---|
| Age, median (range or IQR) | 71 (range: 32-87) | 67 (range: 18-87) |
| Sex, n (%) | ||
| Female | 73 (50) | 60 (48) |
| Male | 74 (50) | 65 (52) |
| AML type, n (%) | ||
| De novo | 97 (66) | 83 (66) |
| Secondary | 50 (34) | 42 (34) |
| Hematologic malignancies, n (%) | ||
| MDS | 39 (26) | 18 (14) |
| Other | 7 (5) | 10 (8) |
| Therapy related | 4 (3) | 14 (11) |
| Cytogenetic risk, n (%) | ||
| Favorable | 6 (4) | – |
| Intermediate | 107 (73) | 66 (53) |
| Poor | 25 (17) | 38 (30) |
| Missing/unknown | 9 (6) | 21 (17) |
| IDH1 mutation, n (%) | ||
| R132C | 90 (61) | 76 (61) |
| R132H | 34 (23) | 27 (22) |
| R132G/S/L | 23 (15) | 19 (15) |
| Wild-type/other | – | 3 (2) |
| Comutations, n (%) | ||
| NPM1 | 31 (21) | 24 (20) |
| FLT3 | 15 (10) | 9 (8) |
| CEBPA | <10% | 3 (3) |
| Prior regimens, median (range or IQR) | 2 (range: 1-7) | 2 (range: 1-6) |
| Venetoclax, n (%) | 12 (8) | 0 |
| HSCT, n (%) | 17 (12) | 36 (29) |
| ECOG PS, n (%) | ||
| 0 | 45 (31) | 27 (22) |
| 1 | 76 (52) | 64 (51) |
| 2 | 23 (16) | 32 (26) |
| 3 | 0 | 2 (1) |
| Bone marrow blast percentage, median (range) | 42 (4-98) | 56 (0-98) |
| Response outcomes | ||
| Composite CR rate (CR + CRh) | 35% | 30% |
| CR rate | 32% | 21% |
| ORR (CR + CRh + CRi + PR + MLFS) | 48% | 42% |
| HSCT | 11% | 12% |
| Duration of responses | ||
| Median time to CR/CRh | 1.9 mo | 2.7 mo |
| Median duration of CR/CRh | 25.9 mo | 8.2 mo |
| Median duration of CR | 28.1 mo | 9.3 mo |
| Median duration of overall response | 11.7 mo | 6.5 mo |
| Survival outcomes | ||
| 18-mo survival rate for patients with CR/CRh | 78% | 50% |
| Median OS | 11.6 mo∗ | 8.8 mo |
| Efficacy evaluable population . | Olutasidenib32 N = 147 . | Ivosidenib15 N = 125 . |
|---|---|---|
| Age, median (range or IQR) | 71 (range: 32-87) | 67 (range: 18-87) |
| Sex, n (%) | ||
| Female | 73 (50) | 60 (48) |
| Male | 74 (50) | 65 (52) |
| AML type, n (%) | ||
| De novo | 97 (66) | 83 (66) |
| Secondary | 50 (34) | 42 (34) |
| Hematologic malignancies, n (%) | ||
| MDS | 39 (26) | 18 (14) |
| Other | 7 (5) | 10 (8) |
| Therapy related | 4 (3) | 14 (11) |
| Cytogenetic risk, n (%) | ||
| Favorable | 6 (4) | – |
| Intermediate | 107 (73) | 66 (53) |
| Poor | 25 (17) | 38 (30) |
| Missing/unknown | 9 (6) | 21 (17) |
| IDH1 mutation, n (%) | ||
| R132C | 90 (61) | 76 (61) |
| R132H | 34 (23) | 27 (22) |
| R132G/S/L | 23 (15) | 19 (15) |
| Wild-type/other | – | 3 (2) |
| Comutations, n (%) | ||
| NPM1 | 31 (21) | 24 (20) |
| FLT3 | 15 (10) | 9 (8) |
| CEBPA | <10% | 3 (3) |
| Prior regimens, median (range or IQR) | 2 (range: 1-7) | 2 (range: 1-6) |
| Venetoclax, n (%) | 12 (8) | 0 |
| HSCT, n (%) | 17 (12) | 36 (29) |
| ECOG PS, n (%) | ||
| 0 | 45 (31) | 27 (22) |
| 1 | 76 (52) | 64 (51) |
| 2 | 23 (16) | 32 (26) |
| 3 | 0 | 2 (1) |
| Bone marrow blast percentage, median (range) | 42 (4-98) | 56 (0-98) |
| Response outcomes | ||
| Composite CR rate (CR + CRh) | 35% | 30% |
| CR rate | 32% | 21% |
| ORR (CR + CRh + CRi + PR + MLFS) | 48% | 42% |
| HSCT | 11% | 12% |
| Duration of responses | ||
| Median time to CR/CRh | 1.9 mo | 2.7 mo |
| Median duration of CR/CRh | 25.9 mo | 8.2 mo |
| Median duration of CR | 28.1 mo | 9.3 mo |
| Median duration of overall response | 11.7 mo | 6.5 mo |
| Survival outcomes | ||
| 18-mo survival rate for patients with CR/CRh | 78% | 50% |
| Median OS | 11.6 mo∗ | 8.8 mo |
ECOG PS, Eastern Cooperative Oncology Group performance status; IQR, interquartile range; MLFS, morphologic leukemia-free survival; PR, partial response.
In the 153-patient safety population (which included the 147-patient efficacy evaluable population plus 6 patients with lack of a centrally confirmed IDH1 mutation).