Comparison of baseline demographics and efficacy outcomes in patients with R/R IDH1mut AML treated on the pivotal registrational trials of IVO and OLU
| Efficacy-evaluable population . | IVO N = 125 . | OLU N = 147 . |
|---|---|---|
| Age, median (range or IQR) | 67 (18-87) | 71 (range, 32-87) |
| ECOG PS, n (%) | ||
| 0 | 27 (22) | 45 (31) |
| 1 | 64 (51) | 76 (52) |
| 2 | 32 (26) | 23 (16) |
| 3 | 2 (1) | 0 |
| AML type, n (%) | ||
| De novo | 83 (66) | 97 (66) |
| Secondary | 42 (34) | 50 (34) |
| Cytogenetic risk, n (%) | ||
| Favorable | – | 6 (4) |
| Intermediate | 66 (53) | 107 (73) |
| Poor | 38 (30) | 25 (17) |
| Missing/unknown | 21 (17) | 9 (6) |
| Co-mutations, n (%) | ||
| NPM1 | 24 (20) | 31 (21) |
| FLT3 | 9 (8) | 15 (10) |
| CEBPA | 3 (3) | <10% |
| Prior regimens, median (range) | 2 (1-6) | 2 (1-7) |
| VEN, n (%) | 0 | 12 (8) |
| HSCT, n (%) | 36 (29) | 17 (12) |
| Bone marrow blast percentage, median (range) | 56 (0-98) | 42 (4-98) |
| Response outcomes | ||
| Composite CR (CR plus CRh) rate | 30% | 35% |
| CR rate | 21% | 32% |
| Duration of response (mo) | ||
| Median time to CR/CRh (range) | 2.7 (0.9-5.6) | 1.9 (0.9-5.6) |
| Median duration of CR/CRh (95% CI) | 8.2 (5.5-12.0) | 25.9 (13.5-NE) |
| Survival outcomes (mo or percentage) | ||
| Median OS (95% CI) | 8.8 (6.7-10.2) | 11.6 (8.9-15.5)* |
| Estimated 18-mo survival probability in patients with CR/CRh | 50% | 78% |
| Efficacy-evaluable population . | IVO N = 125 . | OLU N = 147 . |
|---|---|---|
| Age, median (range or IQR) | 67 (18-87) | 71 (range, 32-87) |
| ECOG PS, n (%) | ||
| 0 | 27 (22) | 45 (31) |
| 1 | 64 (51) | 76 (52) |
| 2 | 32 (26) | 23 (16) |
| 3 | 2 (1) | 0 |
| AML type, n (%) | ||
| De novo | 83 (66) | 97 (66) |
| Secondary | 42 (34) | 50 (34) |
| Cytogenetic risk, n (%) | ||
| Favorable | – | 6 (4) |
| Intermediate | 66 (53) | 107 (73) |
| Poor | 38 (30) | 25 (17) |
| Missing/unknown | 21 (17) | 9 (6) |
| Co-mutations, n (%) | ||
| NPM1 | 24 (20) | 31 (21) |
| FLT3 | 9 (8) | 15 (10) |
| CEBPA | 3 (3) | <10% |
| Prior regimens, median (range) | 2 (1-6) | 2 (1-7) |
| VEN, n (%) | 0 | 12 (8) |
| HSCT, n (%) | 36 (29) | 17 (12) |
| Bone marrow blast percentage, median (range) | 56 (0-98) | 42 (4-98) |
| Response outcomes | ||
| Composite CR (CR plus CRh) rate | 30% | 35% |
| CR rate | 21% | 32% |
| Duration of response (mo) | ||
| Median time to CR/CRh (range) | 2.7 (0.9-5.6) | 1.9 (0.9-5.6) |
| Median duration of CR/CRh (95% CI) | 8.2 (5.5-12.0) | 25.9 (13.5-NE) |
| Survival outcomes (mo or percentage) | ||
| Median OS (95% CI) | 8.8 (6.7-10.2) | 11.6 (8.9-15.5)* |
| Estimated 18-mo survival probability in patients with CR/CRh | 50% | 78% |
ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; PS, performance status.
In the 153-patient safety population (which included the 147-patient efficacy-evaluable population plus 6 patients with a lack of a centrally confirmed IDH1 mutation).
Adapted from Venugopal and Watts.41