Table 2 Summary of select ongoing or planned trials evaluating menin inhibitors combined with standard of care therapies
From: Menin inhibitors for the treatment of acute myeloid leukemia: challenges and opportunities ahead
Age | Phase | Agent | Indication and line of therapy | Combination regimen | Results |
|---|---|---|---|---|---|
Adults > 18 years | I | Ziftomenib (KO-539) KOMET-007 (NCT05735184) | Upfront and R/R AML with KMT2Ar and NPM1m | 7 + 3; (Daunorubicin cytarabine); Venetoclax. Azacitidine, and Venetoclax | In accrual |
Adults > 18 years | I | Ziftomenib (KO-539) KOMET-008 (NCT06001788) | R/R AML with NPM1m and KMT2Ar, FLT3m | FLAG-IDA; LDAC; Gilteritinib | In accrual |
Adults > 18 years | Ib | Revumenib (SNDX-5613) (NCT05886049) | Upfront AML with NPM1m and KMT2Ar | 7 + 3 (Daunorubicin cytarabine) | In accrual |
Adults > 18 years | I/II | Revumenib (SNDX-5613) SAVE trial (NCT05360160) | Upfront AML with NPM1m and KMT2Ar | ASTX (oral Decitabine-Cedazuridine) | In accrual |
Pediatric and young adults 1–30 years | I | Revumenib (SNDX-5613) (NCT06177067) | Upfront AML, ALAL KMT2Ar NUP98r, NPM1m or fusion, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A::CREBBP, or SET::NUP214 | Azacitidine and Venetoclax | In accrual |
Children > 12 years, and adults | I/II | Revumenib (SNDX-5613) (NCT06284486) | CR1 or CR2 with detectable MRD NPM1m, or KMT2Ar, or NUP98r AML | Venetoclax | Not yet open |
Adults > 18 years | Ib | Revumenib (SNDX-5613) BEAT-AML[74] (NCT03013998) | Upfront AML with NPM1m and KMT2Ar |  | Composite CR(cCR) of 100% (95% CI: 75.3–100) |
Adults > 18 years | I | Revumenib (SNDX-5613) (NCT06222580) | R/R AML with NPM1m or KMT2Ar, and FLT3m | Gilteritinib | In accrual |
Adults > 18 years | I | Bleximenib (JNJ-75276617(60) (NCT05453903) | R/R AML with NPM1m or KMT2Ar | Azacitidine and Venetoclax | Composite CR(CR/CRh/CRi) of 48% and CR/CRh of 24% |