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Bleximenib in ND AML: Phase III HOVON 181 AML and cAMeLot-2 trial designs
Do you know... In the phase III HOVON 181 AML trial, bleximenib is being evaluated for the treatment of which AML patient population?
Bleximenib is an investigational, selective menin inhibitor that disrupts the abnormal interaction between menin and KMT2A in NPM1-mutated (NPM1m) or KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML), inducing leukemia cell differentiation and apoptosis.1 In the phase Ib ALE1002 trial (NCT05453903), encouraging preliminary clinical activity was observed with bleximenib in combination with intensive chemotherapy (IC) or with venetoclax + azacitidine in patients with newly diagnosed (ND) NPM1m or KMT2Ar AML.2,3 These combinations are being further evaluated in two phase III trials for the treatment of patients with AML.1,4–6 The HOVON 181 AML trial (NCT07223814) is assessing the safety and efficacy of bleximenib vs placebo in combination with standard-of-care IC in patients with NPM1m or KMT2Ar AML who are eligible for IC.4,5 The cAMeLot-2 trial (NCT06852222) is evaluating bleximenib vs placebo in combination with venetoclax + azacitidine in patients with NPM1m or KMT2Ar AML who are ineligible for IC.1,6
Here, we summarize the trial designs of the HOVON 181 AML and cAMeLot-2 trials, which were presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition; December 6–9, 2025, Orlando, US.1,2
This educational resource is independently supported by Johnson & Johnson. All content is developed by SES in collaboration with an expert steering committee. Funders are allowed no influence.
References
- Jabbour E, Sallman D, Briseno-Toomey D, et al. cAMeLot-2: A phase 3 randomized, double-blind, placebo-controlled, study of bleximenib, venetoclax and azacitidine for the treatment of participants with newly diagnosed acute myeloid leukemia harboring KMT2A rearrangements or NPM1 mutations, who are ineligible for intensive chemotherapy. Blood. 2025;146(suppl 1):3429-3431. DOI: 10.1182/blood-2025-3429
- Döhner H, Schuh AC, Recher C, et al. Bleximenib in combination with intensive chemotherapy: A phase 1b study in newly diagnosed acute myeloid leukemia with KMT2A or NPM1 iterations. Poster #5199. Presented at: 67th American Society of Hematology Annual Meeting and Exposition; Dec 6–9, 2025; Orlando, US.
- Wei AH, Reyner JE, Garciaz S, et al. RP2D determination of bleximenib in combination with VEN+AZA: Phase 1b study in ND & R/R AML with KMT2A/NPM1 alterations. Abstract #S137. Presented at: European Hematology Association 2025 Congress; Jun 12–15, 2025; Milan, IT.
- Raajimakers M, Döhner H, Breems D, et al. Bleximenib or placebo in combination with standard induction and consolidation therapy followed by maintenance for the treatment of patients with newly diagnosed KMT2A-rearranged or NPM1-mutant acute myeloid leukemia eligible for intensive chemotherapy: A double-blind phase 3 study (HOVON 181 AML / AMLSG 37-25). Poster #1654. Presented at: 67th American Society of Hematology Annual Meeting and Exposition; Dec 6–9, 2025; Orlando, US.
- ClinicalTrials.gov. Bleximenib in combination with standard induction and consolidation therapy followed by maintenance for treatment of patients with acute myeloid leukemia (AML). https://clinicaltrials.gov/study/NCT07223814. Updated Oct 8, 2026. Accessed Oct 14, 2026.
- ClinicalTrials.gov. A study of bleximenib, venetoclax and azacitidine for treatment of participants with newly diagnosed acute myeloid leukemia (AML) (cAMeLot-2). https://clinicaltrials.gov/study/NCT06852222. Updated Sep 25, 2026. Accessed Oct 6, 2026.
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