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Real world (RW) use of venetoclax (VEN) in patients (pts) with acute myeloid leukemia (AML) in a US RWE database (COTA)

Acute myeloid leukemia (AML) is a challenging hematologic malignancy associated with poor prognosis and limited treatment options. Venetoclax (VEN), a BCL-2 inhibitor, has emerged as a promising therapeutic agent for AML patients. Understanding the real-world utilization and outcomes of venetoclax in AML is essential for optimizing treatment strategies and improving patient care. This study aims to analyze the real-world data from a US-based real-world evidence (RWE) database, COTA, to gain insights into the use of venetoclax in AML patients.

Methods:
A retrospective analysis was conducted using data from the COTA database, which comprises longitudinal electronic health records (EHR) from multiple healthcare institutions across the United States. Patients diagnosed with AML and treated with venetoclax were identified using specific coding algorithms and clinical criteria. Baseline characteristics, treatment patterns, clinical outcomes, and adverse events were analyzed descriptively.

Results:
The analysis included a cohort of AML patients treated with venetoclax from the COTA database. The cohort exhibited diverse demographic characteristics, including age, sex, and disease risk profiles. The real-world utilization of venetoclax varied across different patient subgroups, reflecting clinical heterogeneity and treatment preferences. Commonly observed treatment patterns included venetoclax monotherapy, combination therapy with hypomethylating agents (HMA), and sequential use following prior therapies.

Clinical outcomes, such as overall response rate, duration of response, and survival endpoints, were assessed and compared across treatment regimens. Additionally, adverse events associated with venetoclax therapy, including hematologic toxicity, infection, and gastrointestinal symptoms, were documented and analyzed.

Discussion:
The real-world data from the COTA database provide valuable insights into the utilization and outcomes of venetoclax in AML patients outside the clinical trial setting. By analyzing diverse patient populations and treatment scenarios, this study elucidates the effectiveness, safety, and tolerability of venetoclax-based regimens in real-world clinical practice.

Conclusion:
The real-world utilization of venetoclax in AML patients, as depicted in the COTA database, underscores the importance of integrating RWE into clinical decision-making and drug development efforts. By leveraging RWE insights, clinicians and researchers can optimize treatment algorithms, identify unmet needs, and drive innovation in AML management. Further studies and collaborative efforts are warranted to validate findings, refine treatment guidelines, and improve outcomes for AML patients receiving venetoclax therapy.