Almost Half of Patients with AML Received Venetoclax Post-Approval

Almost half of patients with acute myeloid leukemia (AML) who initiated therapy after 2018 received first-line venetoclax, a real-world study has found.

In November 2018, venetoclax plus hypomethylating agents (HMAs)/low-dose cytarabine was approved for treatment of patients with AML aged 75 or older or those who were ineligible for intensive chemotherapy. Amer Zeidan, MBBS, MHS, of Yale School of Medicine and Yale Cancer Center, and colleagues conducted a retrospective study to better understand the efficacy and safety of venetoclax in clinical practice.

The results were presented as a poster at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

The researchers identified 3,836 patients with AML in the COTA AML database. Of these, 1,163 patients initiated first-line therapy in or after 2018. First-line venetoclax was initiated in 636 of these patients at any point. The majority of patients treated with venetoclax were seen by community health care providers (64%).

Of the patients who received venetoclax at any point, 47% received it first-line, and the majority (42%) received venetoclax plus an HMA. Among the patients who received another therapy prior to venetoclax, 78% received chemotherapy.

Patients treated with first-line venetoclax compared with chemotherapy were more often treated in community centers (73% vs 56%), had more comorbidities (56% vs 40%), and higher TP53 positivity at baseline (19% vs 10%).

Response data were available for 284 of the patients treated with venetoclax. The complete response rate was 63%. Median overall survival (OS) for venetoclax-treated patients was 14.4 months from first-line therapy initiation. Median OS from diagnosis was 14 months for newly diagnosed disease and 18 months for patients who had received prior chemotherapy.

However, more than half (53%) of patients discontinued at least one venetoclax regimen. Toxicity was the main cause of dose reduction and discontinuation. Median time to discontinuation was 49.5 days.

Reference

Zeidan AM, et al. Real-world (RW) use of venetoclax (VEN) in patients (pts) with acute myeloid leukemia (AML) in a US RWE database (COTA). Abstract # 7044. Presented at the 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, Illinois.