Clinical trial outcomes using HMA, LDAC, BCL-2 inhibition or combination therapy
| Regimen/trial . | Population studied . | FDA approval . | Indication . | ORR, % . | CR, % . | CRi, % . | OS . | Median duration of response . |
|---|---|---|---|---|---|---|---|---|
| Oblimersen/Marcucci et al55 (phase 3) | At diagnosis/in combination with consolidation | No | — | NR | 48 (NS) | NR | 36% 1 y (NS) | NR |
| Venetoclax/Konopleva et al59 (phase 2) | Relapsed or refractory | No | — | 19 | 6 | 13 | NR | 155.6 d |
| Azacitidine/Dombret et al4 (phase 3) | Newly diagnosed AML age ≥65 y, ineligible for SCT | No | — (used off-label for chemotherapy-ineligible patients) | 27.8 | 19.5 | 8.3 | 46% at 1 y; median OS, 10.4 mo | 10.4 mo |
| Decitabine/Kantarjian et al5 (phase 3) | Newly diagnosed AML age ≥65 y, | No | — (used off-label for chemotherapy-ineligible patients) | 25.6 | 15.7 | 9.9 | Median OS, 7.7 mo (NS) | 4.3 mo |
| Venetoclax 400 mg/azacitidine/Dinardo et al60 (phase 1b) | Newly diagnosed AML age ≥65 y, unfit for intensive chemotherapy | Yes | ≥75 or those who are ineligible for induction chemotherapy because of comorbidities | 76 | 44 | 27 | Median OS, 16.9 mo | 21.2 mo |
| Venetoclax 400 mg/decitabine/Dinardo et al60 (phase 1b) | Newly diagnosed AML age ≥65 y, unfit for intensive chemotherapy | Yes | ≥75 or those who are ineligible for induction chemotherapy due because of comorbidities | 71 | 55 | 19 | Median OS, 16.2 mo | 15 mo |
| Venetoclax 600 mg/LDAC/Wei et al7 (phase 1b/2) | Newly diagnosed AML age ≥65 y, unfit for intensive chemotherapy | Yes | ≥75 or those who are ineligible for induction chemotherapy because of comorbidities | 54 | 26 | 28 | Median OS, 10.1 mo | 8.1 mo |
| Regimen/trial . | Population studied . | FDA approval . | Indication . | ORR, % . | CR, % . | CRi, % . | OS . | Median duration of response . |
|---|---|---|---|---|---|---|---|---|
| Oblimersen/Marcucci et al55 (phase 3) | At diagnosis/in combination with consolidation | No | — | NR | 48 (NS) | NR | 36% 1 y (NS) | NR |
| Venetoclax/Konopleva et al59 (phase 2) | Relapsed or refractory | No | — | 19 | 6 | 13 | NR | 155.6 d |
| Azacitidine/Dombret et al4 (phase 3) | Newly diagnosed AML age ≥65 y, ineligible for SCT | No | — (used off-label for chemotherapy-ineligible patients) | 27.8 | 19.5 | 8.3 | 46% at 1 y; median OS, 10.4 mo | 10.4 mo |
| Decitabine/Kantarjian et al5 (phase 3) | Newly diagnosed AML age ≥65 y, | No | — (used off-label for chemotherapy-ineligible patients) | 25.6 | 15.7 | 9.9 | Median OS, 7.7 mo (NS) | 4.3 mo |
| Venetoclax 400 mg/azacitidine/Dinardo et al60 (phase 1b) | Newly diagnosed AML age ≥65 y, unfit for intensive chemotherapy | Yes | ≥75 or those who are ineligible for induction chemotherapy because of comorbidities | 76 | 44 | 27 | Median OS, 16.9 mo | 21.2 mo |
| Venetoclax 400 mg/decitabine/Dinardo et al60 (phase 1b) | Newly diagnosed AML age ≥65 y, unfit for intensive chemotherapy | Yes | ≥75 or those who are ineligible for induction chemotherapy due because of comorbidities | 71 | 55 | 19 | Median OS, 16.2 mo | 15 mo |
| Venetoclax 600 mg/LDAC/Wei et al7 (phase 1b/2) | Newly diagnosed AML age ≥65 y, unfit for intensive chemotherapy | Yes | ≥75 or those who are ineligible for induction chemotherapy because of comorbidities | 54 | 26 | 28 | Median OS, 10.1 mo | 8.1 mo |
NR, not reported; NS, not significant.