Table 2.
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. | ||||
*
Poor cytogenic risk group reported, no separate TP53 mutated subset data available.