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Phase Ib CAVEAT trial: Venetoclax plus chemotherapy in elderly patients with NPM1 or IDH1/IDH2-mutated de novo AML
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Venetoclax plus azacitidine represents a key advance for older, unfit patients with AML. The phase Ib CAVEAT study (ACTRN12616000445471) investigated the use of intensified therapy in patients with AML aged ≥65 years (N = 85), including patients with TP53 mutations. Venetoclax + cytarabine + idarubicin was used as the induction regimen, followed by four rounds of consolidation and seven cycles of maintenance therapy.1 Results from the trial were published by Chua et al.1 in Blood Advances, reporting the efficacy and tolerability of venetoclax plus intensive chemotherapy in elderly patients with NPM1 or IDH1/IDH2-mutated de novo AML. The primary endpoint was ORR.1 |
| Key learnings |
| At a median follow-up of 41.8 months, the ORR was 75%, with a CR rate of 56%. |
| The median OS was 19.3 months, extending to 33.1 months in de novo AML cases. The 2-year and 3-year OS rates were 48% and 33%, respectively. |
| Modified regimens, including lower venetoclax doses with posaconazole and omitting idarubicin in consolidation, improved hematologic recovery. Low rates of tumor lysis syndrome (4%) and 30-day mortality (4%) and limited Grade >3 GI toxicity were reported (15%). |
| The study confirms that venetoclax-based therapy is effective and tolerable in elderly patients with AML, particularly for patients with NPM1 and IDH1/2 mutated de novo AML. Future research will explore maintenance strategies to sustain long-term remission. |
Abbreviations: AML, acute myeloid leukemia; CR, complete remission; GI, gastrointestinal; ORR, overall response rate; OS, overall survival.
- Chua CC, Loo S, Fong CY, et al. Final analysis of the phase 1b chemotherapy and venetoclax in elderly acute myeloid leukaemia trial (CAVEAT). Blood Adv. Online ahead of print. DOI: https://doi.org/10.1182/bloodadvances.2024014900
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