Response rates in patients with newly diagnosed AML
| Response category . | Ivosidenib 500 mg, n = 33* . |
|---|---|
| CR + CRh rate, n (%) [95% CI] | 14 (42.4) [25.5-60.8] |
| Time to CR/CRh, median (range), mo | 2.8 (1.9-12.9) |
| Duration of CR/CRh, median [95% CI], mo | NE [4.6 to NE] |
| CR rate, n (%) [95% CI] | 10 (30.3) [15.6-48.7] |
| Time to CR, median (range), mo | 2.8 (1.9-4.6) |
| Duration of CR, median [95% CI], mo | NE [4.2 to NE] |
| CRh rate, n (%) [95% CI] | 4 (12.1) [3.4-28.2] |
| Time to CRh, median (range), mo | 3.7 (1.9-12.9) |
| Duration of CRh, median [95% CI], mo | 6.5 [2.8 to NE] |
| ORR by IWG, n (%) [95% CI]† | 18 (54.5) [36.4-71.9] |
| Time to first response, median (range), mo | 1.9 (0.9-3.6) |
| Duration of response, median [95% CI], mo | NE [4.6 to NE] |
| Best response by IWG, n (%) | |
| CR | 10 (30.3) |
| CRi or CRp | 6 (18.2) |
| PR | 1 (3.0) |
| MLFS | 1 (3.0) |
| SD | 10 (30.3) |
| PD | 3 (9.1) |
| Not assessed | 2 (6.1) |
| Response category . | Ivosidenib 500 mg, n = 33* . |
|---|---|
| CR + CRh rate, n (%) [95% CI] | 14 (42.4) [25.5-60.8] |
| Time to CR/CRh, median (range), mo | 2.8 (1.9-12.9) |
| Duration of CR/CRh, median [95% CI], mo | NE [4.6 to NE] |
| CR rate, n (%) [95% CI] | 10 (30.3) [15.6-48.7] |
| Time to CR, median (range), mo | 2.8 (1.9-4.6) |
| Duration of CR, median [95% CI], mo | NE [4.2 to NE] |
| CRh rate, n (%) [95% CI] | 4 (12.1) [3.4-28.2] |
| Time to CRh, median (range), mo | 3.7 (1.9-12.9) |
| Duration of CRh, median [95% CI], mo | 6.5 [2.8 to NE] |
| ORR by IWG, n (%) [95% CI]† | 18 (54.5) [36.4-71.9] |
| Time to first response, median (range), mo | 1.9 (0.9-3.6) |
| Duration of response, median [95% CI], mo | NE [4.6 to NE] |
| Best response by IWG, n (%) | |
| CR | 10 (30.3) |
| CRi or CRp | 6 (18.2) |
| PR | 1 (3.0) |
| MLFS | 1 (3.0) |
| SD | 10 (30.3) |
| PD | 3 (9.1) |
| Not assessed | 2 (6.1) |
CRi, CR with incomplete hematologic recovery; CRp, CR with incomplete platelet recovery; MLFS, morphologic leukemia-free state; NE, not estimable; ORR, overall response rate; PD, progressive disease; PR, partial response; SD, stable disease.
One patient enrolled in dose-escalation phase was positive for the IDH1-D54N mutation by local testing and was not positive for the IDH1-R132 mutation by the companion diagnostic test; this patient was therefore excluded from the efficacy analyses.
ORR = CR + CRi + CRp + PR + MLFS. IWG responses, including CR, were reported by investigators. CRh was derived by the sponsor and defined as bone marrow myeloblasts of <5% combined with both absolute neutrophil count >500/μL and platelet count >50 × 109/L.