Table 1.
Menin inhibitors currently available in phase I/II clinical trials for patients with acute leukemia.
| Drug | Trial (ClinicalTrials.gov ID) |
Phase | Regimen | Patient Population |
Eligibility |
|---|---|---|---|---|---|
|
Revumenib
(SNDX-5613) |
AUGMENT-101 (NCT04065399) | I/II | Revumenib monotherapy | 131 Adults and children | R/R KMT2Ar AL, NPM1c AML |
| AUGMENT-102 (NCT05326516) | I | -AML: Revumenib/FLA ± Revumenib/FLA -ALL/MPAL: Revumenib/Pred/VCR/ASP/DNR |
30 Adults and children | R/R KMT2Ar AL, NPM1c or NUP98r AML | |
| (NCT05761171) | II | Revumenib/FLA, MTX | Children (recruiting) | R/R KMT2Ar ALL | |
|
SAVE
(NCT05360160) |
I/II | Revumenib/ASTX727/VEN | 8 Adults and children (recruiting) | R/R AML or MPAL | |
| BeatAML substudy (NCT03013998) | I | Revumenib/VEN/AZA | 13 Adults | Newly diagnosed KMT2Ar or NPM1c AML | |
|
Ziftomenib
(KO-539) |
KOMET-001
(NCT 04067336) |
I/II | Ziftomenib monotherapy | 30 Adults | Phase 1a: R/R AML Phase 1b/2: KMT2Ar or NPM1c AML |
|
KOMET-007
(NCT05735184) |
I | -Newly diagnosed AML: Ziftomenib/7 + 3 -R/R AML: ziftomenib/VEN/AZA |
20 Adults | Newly diagnosed and R/R KMT2Ar or NPM1c AML | |
| JNJ-75276617 | NCT04811560 | I | JNJ-75276617 monotherapy | 58 Adults | R/R KMT2Ar AL, NPM1c AML |
| NCT05453903 | I | JNJ-75276617/VEN, JNJ-75276617/AZA or JNJ-75276617/VEN/AZA | Adults (recruiting) | R/R KMT2Ar AL, NPM1c AML | |
| NCT05521087 | I | AML: JNJ-75276617/FLA ALL: JNJ-75276617/DEX/VCR/ASP | Adults and children (recruiting) | R/R KMT2Ar AL, NPM1c ALL/AML, NPM1c or NUP98r AML | |
| BMF-219 | COVALENT-101 (NCT05153330) | I | BMF-219 monotherapy | 26 Adults | R/R AL, DLBCL or MM |
| DS-1594 | NCT04752163 | I/II | DS-1594 = AZA, VEN or mini-HCVD | 17 Adults | Phase 1: R/R AL Phase 2: R/R KMT2Ar ALL/AML, NPM1c AML |
| DSP-5336 | NCT04988555 | I/II | DSP-5336 monotherapy | 4 Adults | Phase 1: R/R AL Phase 2: R/R KMT2Ar ALL/AML, NPM1c AML |
From clinicaltrials.gov. AL, acute leukemia; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; ASP, PEG-asparaginase; AZA, azacytidine; CPM, cyclophosphamide; DEX, dexamethasone; DNR, daunorubicine; DLBCL, diffuse large B-cell lymphoma; ETO, etoposide; FLA, fludarabine and cytarabine; MPAL, mixed-phenotype acute leukemia; mini-HCVD, cyclophosphamide, cytarabine, dexamethasone, methotrexate, prednisolone, rituximab and vincristine; MTX, methotrexate; MM, multiple myeloma; Pred, prednisolone; R/R, refractory or relapse; VCR, vincristine; VEN, venetoclax; 7 + 3, cytarabine and anthracycline.