Representative efficacy outcomes in AML subsets
| Regimen . | Response rates . | Overall survival . | ||
|---|---|---|---|---|
| All groups . | TP53 . | All groups . | TP53 . | |
| Intensive regimens | ||||
| 7 + 3 (cytarabine and anthracycline)2,11,12,37 | CR: 35%-71% CR/CRi: 40%-71% sAML subset: CR: 26%-52% CR/CRi: 33%-55% | CR: 30%-34% CR/CRi: 40% | sAML subset: 5-10 mo | 5-6 mo |
| CPX-351 (liposomal cytarabine and daunorubicin)12,16,37 | sAML subset: CR: 7%-12% CR/CRi: 45%-48% | CR: 29% CR/CRi: 29% | sAML subset: 10-13 mo | 4-6 mo |
| Nonintensive regimens | ||||
| Azacitidine and venetoclax16,17,21 | CR: 40% CR/CRi: 65% sAML subset: CR/CRi: 60% | CR: NA CR/CRi: 50%-55% | 11-16 mo sAML subset: 11-16 mo | 5-7 mo |
| Azacitidine or decitabine monotherapy21,38 | CR: 13%-24% CR/CRi: 18%-27% sAML subset: CR/CRi: 25% | CR: 24%-40% CR/CRi: 0%-40% | 6-11 mo sAML subset: 7-8 mo | 2-7 mo |
| Low-dose cytarabine (LoDAC)38-40 | CR: 3%-24% CR/CRi: 5%-34% sAML subset: CR: 0% | CR: 0%-11% CR/CRi: 0%-22% | 4-5 mo sAML subset: 4 mo | 2-3 mo |
| Glasdegib and LoDAC41,42 | CR: 18% CR/CRi: 24% sAML subset: CR: 24% | CR: 24%* CR/CRi: NA | 8-9 mo sAML subset: 9 mo | 5-6 mo* |
| Experimental regimens | ||||
| CD47/SIRPα inhibitors with HMA (eg, magrolimab)35 | CR: 44% CR/CRi: 56% | CR: 48% CR/CRi: 67% | 18.9 mo | 12.9 mo |
| TIM-3 inhibitors with HMA (eg, sabatolimab)43 | NA | CR: 25% CR/CRi: 30% | NA | NA |
| Bispecific antibody therapies (eg, flotetuzumab) in R/R AML44 | NA | CR: 27% CR/CRi: 40% | NA | 4.5 mo |
| Representative efficacy outcomes in subsets of acute myeloid leukemia with myelodysplasia-related changes, therapy-related myeloid neoplasm, and TP53. Early clinical trial data are presented for representative experimental regimens with listed agents. | ||||
| CRi, complete remission with incomplete count recovery; HMA, hypomethylating agent; NA, not available; R/R, relapsed refractory disease; sAML, secondary AML. | ||||
| Regimen . | Response rates . | Overall survival . | ||
|---|---|---|---|---|
| All groups . | TP53 . | All groups . | TP53 . | |
| Intensive regimens | ||||
| 7 + 3 (cytarabine and anthracycline)2,11,12,37 | CR: 35%-71% CR/CRi: 40%-71% sAML subset: CR: 26%-52% CR/CRi: 33%-55% | CR: 30%-34% CR/CRi: 40% | sAML subset: 5-10 mo | 5-6 mo |
| CPX-351 (liposomal cytarabine and daunorubicin)12,16,37 | sAML subset: CR: 7%-12% CR/CRi: 45%-48% | CR: 29% CR/CRi: 29% | sAML subset: 10-13 mo | 4-6 mo |
| Nonintensive regimens | ||||
| Azacitidine and venetoclax16,17,21 | CR: 40% CR/CRi: 65% sAML subset: CR/CRi: 60% | CR: NA CR/CRi: 50%-55% | 11-16 mo sAML subset: 11-16 mo | 5-7 mo |
| Azacitidine or decitabine monotherapy21,38 | CR: 13%-24% CR/CRi: 18%-27% sAML subset: CR/CRi: 25% | CR: 24%-40% CR/CRi: 0%-40% | 6-11 mo sAML subset: 7-8 mo | 2-7 mo |
| Low-dose cytarabine (LoDAC)38-40 | CR: 3%-24% CR/CRi: 5%-34% sAML subset: CR: 0% | CR: 0%-11% CR/CRi: 0%-22% | 4-5 mo sAML subset: 4 mo | 2-3 mo |
| Glasdegib and LoDAC41,42 | CR: 18% CR/CRi: 24% sAML subset: CR: 24% | CR: 24%* CR/CRi: NA | 8-9 mo sAML subset: 9 mo | 5-6 mo* |
| Experimental regimens | ||||
| CD47/SIRPα inhibitors with HMA (eg, magrolimab)35 | CR: 44% CR/CRi: 56% | CR: 48% CR/CRi: 67% | 18.9 mo | 12.9 mo |
| TIM-3 inhibitors with HMA (eg, sabatolimab)43 | NA | CR: 25% CR/CRi: 30% | NA | NA |
| Bispecific antibody therapies (eg, flotetuzumab) in R/R AML44 | NA | CR: 27% CR/CRi: 40% | NA | 4.5 mo |
| Representative efficacy outcomes in subsets of acute myeloid leukemia with myelodysplasia-related changes, therapy-related myeloid neoplasm, and TP53. Early clinical trial data are presented for representative experimental regimens with listed agents. | ||||
| CRi, complete remission with incomplete count recovery; HMA, hypomethylating agent; NA, not available; R/R, relapsed refractory disease; sAML, secondary AML. | ||||
Poor cytogenic risk group reported, no separate TP53 mutated subset data available.