Reviewing the Benefits of a Treatment for Patients With Acute Myeloid Leukemia

Michael Werner, PhD, scientific director of oncology for US medical affairs, AbbVie, discusses recent study findings presented at ASCO 2021, highlighting the efficacy of venetoclax for the treatment of acute myeloid leukemia.  

Please briefly describe your research and its findings. Were any of the outcomes particularly surprising?

A few of our continued studies of VIALE-A in myeloid malignancies were shared at this year’s American Society of Clinical Oncology (ASCO) including abstract #7018 (Measurable Residual Disease Response in Acute Myeloid Leukemia Treated with Venetoclax and Azacitidine). Analysis of the phase 3 VIALE-A trial venetoclax + azacitidine arm showed that patients who achieved a composite complete remission (CRc) and had samples available for MRD analysis, 41% achieved a minimal residual disease (MRD) response less than 0.1%, with 59% achieving a CRc with MRD ≥ 0.1%. There were no differences in baseline or disease characteristics between the two groups, except for a numerically higher incidence of NPM1 mutations in the MRD < 0.1% response group. At the median follow-up of 22 months, patients with best response of CRc who achieved MRD < 0.1% treated with venetoclax plus azacitidine had longer duration of response (DoR), overall survival (OS), and event-free survival (EFS) than patients who were CRc and MRD ≥ 0.1%.   

Another presented at ASCO was abstract #7011 (Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Therapy-Related Myeloid Neoplasms, Antecedent Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms), which evaluated patients with newly diagnosed AML classified as either therapy-related myeloid neoplasms (tMN) or newly diagnosed AML that progressed from an antecedent myelodysplastic syndrome or antecedent myelodysplastic/myeloproliferative neoplasms (A-MDS/MPN). Newly diagnosed AML arising from prior therapy or an antecedent hematologic disorder may have poor outcomes due to age and adverse genetic features seen in this subset of AML. In this pooled analysis of the Phase 3 VIALE-A study and an earlier Phase1B study, patients with tMN and A-MDS/MPN who are unfit for intensive chemotherapy treated with venetoclax and azacitidine demonstrated higher CRc rates and improvements in OS compared to patients treated with azacitidine alone. The safety profile of venetoclax + azacitidine in this population was similar to overall patient population in the trials. 

Do you intend to expand upon this research? Is there anything else pertaining to your research and findings that you would like to add?

We are continuing to evaluate venetoclax across a wide range of settings to expand our understanding of the full benefit of this treatment in myeloid malignancies. Although a lot of progress has been made in that area, there is still a lot of high unmet need, and we look forward to transforming the standards of care for patients. 

About Dr Werner

Dr Werner is the scientific director of oncology for US medical affairs at AbbVie. He is a research scientist by training with a focus on mechanisms of cell death and has been working in the oncology therapeutic area and biopharmaceutical industry for over 15 years.