P090 | ACUTE MYELOID LEUKEMIA TREATED WITH VENETOCLAX IN COMBINATION WITH HYPOMETHYLATING AGENTS: A RETROSPECTIVE, MONOCENTRIC STUDY.

According to the most recent European Leukemia Net guidelines, the association of venetoclax (VEN) plus hypomethylating agents (HMAs) is considered the standard-of-care for patients with acute myeloid leukemia (AML) unfit for intensive chemotherapy (IC). We collected data of AML patients treated with a combination of HMAs [decitabine (DEC) or azacitidine (AZA)] and VEN at Hematology Unit of Cosenza hospital from May 2021 to January 2025. Fifty patients received at least 1 cycle of treatment (62% AZA-VEN and 38% DEC-VEN) between May 2021 and January 2025. Thirty patients (60%) were male, median age 75 years (range 58-89) and 24% showed an ECOG PS of 2; 36% showed a secondary AML and 46% high-risk cytogenetic features. In 94% of cases the HMA-VEN combination represented the first line of therapy. The safety analysis showed that 14 patients (28%) developed sepsis (7 fatal ones), 4 patients (8%) developed atrial fibrillation. No new and unexpected toxicities have been reported. After a median follow-up of 12.5 months, overall response rate was 42% (21/50 patients), the median overall survival (OS) was 8 months (95% CI 5.4-10.4). Twenty-five patients completed less than 4 cycles of treatment: 1 underwent alloSCT, 2 were lost at follow-up, 3 are still on treatment, 19 patients died (12 due to an infection, 6 for disease progression, 1 for larynx neoplasm). A sub-analysis of the 25 patients who received at least 4 cycles has been performed. Baseline characteristics of these 25 patients are reported in the Table 1. After a median follow-up 12 months (95% CI 11,5-14,4), patients received a median of 8 cycles (range 4-32). The median OS was 12 months (95% CI 8-14), with no difference between de novo and secondary AML (p=0.8). Among 16 red blood cells transfusion dependent patients and 11 platelets transfusion dependent patients 8 (50%) and 5 (45.5%) reach transfusion independency, respectively. HMAs plus VEN has become the gold standard for unfit AML patients. In our small population we notice a good efficacy in those who received at least 4 cycles. Interestingly, in this subset no difference was seen between those with de novo and secondary AML, suggesting that this combination could be effective also in this latter challenging setting. The retrospective nature of the study and the very small size of patients represent limitations of the present study. Larger cohorts are needed to explore the safety and efficacy of the combination of HMAs and VEN in real life setting.