Final analysis of the phase 1b Chemotherapy and Venetoclax in Elderly Acute Myeloid Leukemia Trial (CAVEAT)

• DOI: 10.1182/bloodadvances.2024014900
• Publication Date: 2025-01-18T14:57:10Z
• Authors: Chong Chyn Chua; Sun Loo; Chun Yew Fong; Stephen B. Ting; Ing Soo Tiong; Shaun Fleming; Natasha S. Anstee; Adam Ivey; Michael Ashby; Tse-Chieh Teh; John Reynolds; Andrew W. Roberts; Andrew H. Wei
• Keywords: Venetoclax; Idarubicin; Induction chemotherapy; Chemotherapy regimen

Venetoclax plus azacitidine represents a key advance for older, unfit patients with acute myeloid leukemia (AML). The chemotherapy and venetoclax in elderly AML trial (CAVEAT) was first to combine intensive newly diagnosed ≥65 years. In this final analysis, 85 (median age 71 years) were followed median of 41.8 months. CAVEAT induction combined cytarabine idarubicin 5 dose levels (50-600 mg) up 14 days. Two additional cohorts explored adjusted-dose (50 mg, 100 posaconazole. well tolerated, low mortality (4%) limited high-grade gastrointestinal toxicity (4%). Delayed hematological recovery after consolidation ameliorated by omitting from post-remission therapy. overall response rate (ORR: CR + CRh CRi) 75% survival (OS) 19.3 months (95% CI 11.1-31.3). Among de novo AML, ORR 88% OS 33.1 19.3-54.3). Almost one-third have not relapsed, many benefiting prolonged treatment-free remission 17.9 months). tolerated associated high that durable, particularly AML. an effective time-limited treatment option fit older (https://www.anzctr.org.au; ACTRN12616000445471).