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

Abstract

7044 Background: VEN + hypomethylating agents (HMAs)/low-dose cytarabine was approved for the treatment (tx) of pts with AML who are ≥75 y or ineligible for intensive chemotherapy (CT) in 11/2018. To understand the use, safety, and efficacy of VEN in clinical practice, the COTA AML database, using pt-level curated electronic health record data from centers across the US, was analyzed. Methods: This is a retrospective, descriptive analysis of deidentified secondary data from the COTA AML database in the US. Data was abstracted for adults diagnosed with AML who initiated first-line (1L) tx on or after 01/01/2018 and received ≥1 VEN tx at any point. Pts with no diagnosis date or with concurrent primary malignancies were excluded. Follow-up was until the last recorded event (last visit or death). The study period for this analysis was 01/2018 to 09/2022. Results: Of 3836 pts with AML in the database, 1163 pts initiated 1L tx in or after 2018; of these, 636 received ≥1 VEN tx at any point. See Table for baseline demographic data. Most VEN-treated pts were seen by community healthcare providers (407/636, 64%). Genetic/molecular data were limited. Of the most frequently tested mutations, the most common were TP53 (129/461, 28%), RUNX1 (109/444, 25%), TET2 (101/414, 24%), ASLX1 (92/417, 22%), and DNMT3A (91/424, 22%). Of pts who received VEN, 47% (299/636) received 1L VEN, and the majority (269/636, 42%) received VEN + HMAs. For pts with tx prior to VEN (pretreated), 262/337 (78%) were previously treated with CT. 1L pts were more often treated in community centers than pretreated pts (73% vs 56%), had more comorbidities (56% vs 40%), and TP53 positivity (19% vs 10%) at baseline. Of 284 VEN-treated pts with available response data, 180 (63%) had a complete response (CR). Median OS (mOS) of VEN-treated pts was 14.4 mo from 1L tx initiation (de novo AML, 17 mo; secondary AML, 14 mo). mOS from diagnosis was 14 mo for newly diagnosed and 18 mo for pretreated pts. Toxicity was the main cause of dose reduction and discontinuation. Median duration of VEN tx was 78 d. Dose reduction was reported in ~30% of VEN-treated pts. Of VEN-treated pts, 53% (338/636) discontinued at least 1 VEN regimen, with a median time to discontinuation of 49.5 d. Conclusions: This study provides an overview of the RW use of VEN in pts with AML in the US since its approval in 11/2018. Despite the study period starting earlier than VEN approval, almost half of pts with AML who initiated tx after 2018 received 1L VEN. The RW CR rate in VEN-treated pts with available data was 63%, but over half of VEN-treated pts had VEN tx discontinuation. [Table: see text]