This seems like a potential future option for older/unfit patients with AML. Small study of 60 patients, treatment was CLAD 5mg/m2 D1-5 + sub-cut LDAC 20mg BID + venetoclax 400mg D1-21. Response rates were very high with CR of 93% and MRD-neg in 84% of patients.
The combination of venetoclax and 5-azacitidine (5-AZA) for older or unfit patients with acute myeloid leukemia (AML) improves remission rates and survival compared with 5-AZA alone. We hypothesized that the addition of venetoclax to cladribine (CLAD)/low-dose araC (low-dose cytarabine [LDAC]) alternating with 5-AZA backbone may further improve outcomes for older patients with newly diagnosed AML.
This is a phase II study investigating the combination of venetoclax and CLAD/LDAC alternating with venetoclax and 5-AZA in older (≥ 60 years) or unfit patients with newly diagnosed AML. The primary objective was composite complete response (CR) rate (CR plus CR with incomplete blood count recovery); secondary end points were overall survival, disease-free survival (DFS), overall response rate, and toxicity.
A total of 60 patients were treated; median age was 68 years (range, 57-84 years). By European LeukemiaNet, 23%, 33%, and 43% were favorable, intermediate, and adverse risk, respectively. Fifty-six of 60 evaluable patients responded (composite CR: 93%) and 84% were negative for measurable residual disease. There was one death (2%) within 4 weeks. With a median follow-up of 22.1 months, the median overall survival and DFS have not yet been reached. The most frequent grade 3/4 nonhematologic adverse events were febrile neutropenia (n = 33) and pneumonia (n = 14). One patient developed grade 4 tumor lysis syndrome.
Venetoclax and CLAD/LDAC alternating with venetoclax and 5-AZA is an effective regimen among older or unfit patients with newly diagnosed AML. The rates of overall survival and DFS are encouraging. Further study of this non–anthracycline-containing backbone in younger patients, unfit for intensive chemotherapy, as well as comparisons to standard frontline therapies is warranted.
Compelling study showing Asciminib vs. investigator’s choice TKi. Asciminib was better tolerated and with deeper molecular responses. This may become a preferred option for many new chronic myeloid leukemia (CML) patients. Cost may be an issue.
Sorafenib did not help in newly diagnosed AML (with FLT-ITD) patients as maintenance therapy. MRD testing can also predict survival outcome.
A small number of patients in this study, but it is an interesting test to predict who can be off therapy in CML. Patients who are high risk probably should to be taken off therapy, but this gives us something to build on.
While use of Hydroxyurea for CMML may not be common practice, it is an option.
High ORR of 89%in patients with HCL using BRAF/MET combination therapy, MRD-neg in 69%. The adage that we have more drugs than patients with HCL still holds true for most of us.
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