Articles related to ACUTE MYELOID LEUKEMIA (AML)

The findings of this randomized clinical trial support the notion that, despite improved DFS, patients 60 years or younger with intermediate-risk AML, as defined by Medical Research Council cytogenetic criteria, do not benefit from allo-HCT during first CR in terms of OS. Early identification of a suitable donor allows for the timely rescue of patients who have relapsed following conventional consolidation chemotherapy. Future research that uses longitudinal monitoring of residual disease dynamics will aid in personalizing the optimal time point for allo-HCT in the majority of patients.

Data from Study 2102-HEM-101, an open-label, single-arm, multicenter phase 1/2 trial, were used to support the approval. The Abbott RealTime IDH1 Assay was used to identify 147 adults with relapsed or refractory AML who had an IHD1 mutation. Olutasidenib treatment resulted in a 35% complete remission (CR) or complete remission with partial hematologic recovery in patients (CRh).

Gilteritinib is standard therapy for relapsed/refractory FLT3-mutated (FLT3mut) AML but seldom reduces FLT3mut burden or induces sustained efficacy. This phase Ib open-label, dose-escalation/dose-expansion study enrolled 61 patients (63% having received prior FLT3 therapy) to receive 400 mg oral venetoclax once daily and 80 mg or 120 mg oral gilteritinib once daily. The combination of venetoclax and gilteritinib was associated with high mCRc and FLT3 molecular response rates regardless of prior FLT3 inhibitor exposure, but did require dose interruptions for myelosuppression.

Even after allogeneic hematopoietic stem-cell transplant (HCT), poor outcomes are typically the case in patients with TP53-mutant (mTP53) acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The data from recent trials using the combination of eprenetapopt (APR-246) and azacitidine showed positive preclinical results in mTP53 AML/MDS, and this trial sought to assess the efficacy and safety of the eprenetapopt and azacitidine combination as maintenance therapy after allogeneic HCT in patients with mTP53 AML or MDS.

The study confirmed the high unmet need among older adults with AML, namely that overall survival (OS) without transplant is poor and consistent with other studies. The authors also remark that a “definitive evidence-based recommendation favoring venetoclax and azacitidine (ven/aza) or CPX-351 in older adults will require a randomized trial.”

The International Consensus Classification (ICC) of myeloid neoplasms and acute leukemia was developed as a result of the recent advances in doctors’ understanding of the biology of hematologic malignancies, the experience with the use of the 2016 WHO classification in clinical practice, and the results of clinical trials.