EHA25 Virtual: Venetoclax Plus Low-Dose Cytarabine for Older Adults With AML
Posted: Tuesday, June 23, 2020
The long-term update of a study investigating venetoclax plus low-dose cytarabine in patients with previously untreated acute myeloid leukemia (AML) was recently presented during the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual; Abstract EP554). After a follow-up of 3.5 years, the median overall survival for study participants—older patients who were ineligible for standard induction chemotherapy—was 10 months, and 22% of patients were alive after 2 years of treatment. “Further analyses to identify baseline features predictive of response with prolonged duration are ongoing,” stated Andrew H. Wei, MBBS, PhD, of The Alfred Hospital, Melbourne, and colleagues.
The phase I/II, open-label study enrolled 82 patients 60 years of age or older with previously untreated AML who were ineligible for standard induction chemotherapy due to advanced age or significant comorbidities. Patients received venetoclax combined with subcutaneous low-dose cytarabine. The median patient age was 74 years, and about half of patients had secondary AML. Baseline mutations in TP53, FLT3, IDH1/2, and NPM1 were detected in 14%, 21%, 26%, and 13% of patients, respectively.
The rate of complete remission plus complete remission with incomplete blood count recovery was 54%, and the median duration of response was 9.8 months. Patients with de novo AML (n = 42) had a complete remission plus complete remission with incomplete blood count recovery rate of 71%, a median duration of response of 10.8 months, and an improved overall survival compared with all patients (15.7 vs. 9.7 months). Conversely, patients previously treated with a hypomethylating agent had lower rates of response (33%) and median overall survival (4.1 months).
After 2 years of treatment, 32%, 36%, and 64% were alive with IDH1/2-, de novo, or NPM1-mutant AML, respectively. As for toxicity, the most common grade 3 or 4 treatment-emergent adverse events were febrile neutropenia (43%), thrombocytopenia (39%), and decreased white blood cell count (34%).
Disclosure: The study authors’ disclosure information may be found at library.ehaweb.org.