Venetoclax Add-On Improves Complete Remission in AML

The study covered in this summary was published on ssrn.com as a preprint and has not yet been peer reviewed.

Key Takeaway

  • Over 90% of adults with acute myeloid leukemia (AML) went into complete remission after one treatment cycle when venetoclax was added to the conventional daunorubicin/cytarabine induction regimen.

Why This Matters

  • Cytarabine plus an anthracycline has been the standard AML induction regimen for decades, but only 60% to 70% of patients achieve complete remission.

  • The study establishes daunorubicin/cytarabine plus venetoclax as a safe and effective option for young adults newly diagnosed with AML.

Study Design

  • Overall, 33 patients with AML underwent induction therapy with daunorubicin (60 mg/m2, days 1–3), cytarabine (100 mg/m2, days 1–7) and venetoclax (100 mg day 4, 200 mg day 5, and 400 mg days 6–11).

  • The median patient age was 40 years.

Key Results

  • The complete remission rate after one cycle of daunorubicin/cytarabine plus venetoclax was 91% overall. Complete remission rates were 100%, 83%, and 75% in European LeukemiaNet (ELN) favorable, intermediate, and poor-risk groups, respectively.

  • At a median follow-up of 6 months, 30 patients were in continuous complete remission.

  • Of the 30 patients who achieved complete remission, 29 (97%) had undetectable measurable residual disease.

  • Patients showed rapid recovery from myelosuppression (median of 21 days).

  • Febrile neutropenia (54%), pneumonia (21%), and sepsis (12%) accounted for most of the grade 3–4 adverse events.

Limitations

  • The study was small, and follow-up time was too short to assess survival benefit; a larger randomized trial is ongoing.

  • The proportion of ELN favorable-risk patients was slightly higher than in previous trials, which might have skewed the results.

Disclosures

  • The work was funded by the Leading Innovative and Entrepreneur Team Introduction Program of Zhejiang and the National Natural Science Foundation of China.

  • The investigators did not disclose any significant financial relationships.

This is a summary of a preprint research study, “Venetoclax Plus ‘3+7’ Chemotherapy as the First-Line Therapy for Adult Patients With Acute Myeloid Leukemia,” led by Huafeng Wang of the Zhejiang University School of Medicine, China. The study has not been peer reviewed. The full text can be found at ssrn.com.

M. Alexander Otto is a physician assistant with a master’s degree in medical science. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape and is an MIT Knight Science Journalism fellow. Email: [email protected]

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