Courtney D. DiNardo, M.D., MSCE Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center


Courtney D. DiNardo, M.D., MSCE Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center

Dr. DiNardo

Courtney D. DiNardo, M.D., MSCE
Department of Leukemia, Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center What is the background for this study?

Response: At this year’s virtual European Hematology Association (EHA) meeting, we are presenting late-breaking data from the Phase 3 VIALE-A trial. The randomized double-blind, placebo-controlled trial evaluated venetoclax in combination with azacitidine in previously-untreated patients with acute myeloid leukemia (AML) who are ineligible for standard induction therapy compared to azacitidine plus placebo. What are the main findings?

Response: Patients treated with the venetoclax combination had significant improvement in overall survival (OS) and composite complete remission rate (CR + Cri), with a 34 percent higher reduction in risk of death when compared to patients in the placebo arm. Patients receiving the venetoclax combination achieved improved median OS (14.7 months versus 9.6 months in the placebo arm), and 66.4 percent of patients treated with venetoclax plus azacitidine had a CR + CRi compared to 28.3 percent treated with azacitidine plus placebo.

The overall safety profile observed in the trial was generally consistent with the profile of the two medications alone and of venetoclax combined with azacitidine. What should readers take away from your report?

Response: AML is a difficult-to-treat blood cancer and the treatment landscape has not evolved enough in the past three decades, especially for patients who cannot withstand intensive chemotherapy. The five-year survival rate for patients with AML remains at approximately 29 percent. Therefore, considering this critical unmet need in elderly or unfit patients with AML, the positive results of this Phase 3 trial have the potential to significantly alter the AML treatment landscape. This is a very exciting time as we continue to learn more about how venetoclax has the potential to help patients achieve prolonged survival without disease progression. What recommendations do you have for future research as a result of this work? 

Response: Based on the positive results of this trial, we are looking forward to diving deeper into post-trial analyses into patient subgroups, in the hopes that a signature will emerge, allowing physicians to more precisely identify patients who will respond to venetoclax treatment. Parameters for future evaluations may include comorbidities, genetic abnormalities, age, and expression profiling of BCL-2 family members. Additional trials could explore the utility of venetoclax in patients with AML who defy easy categorization of fitness, and combinations with various chemotherapy-based induction regimens. Is there anything else you would like to add?

 Response: There have been very few options for patients with AML who are ineligible for intensive chemotherapy and survival rates continue to remain low. Venetoclax in combination with azacitidine provides a potential effective approach for this patient population who desperately needs better options.

Disclosures: Dr. DiNardo has received honoraria and research funding from AbbVie. 

Citation: EHA 2020




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Last Updated on June 16, 2020 by Marie Benz MD FAAD