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Can Adding Venetoclax to FLAG-IDA Regimen Improve Outcomes in Patients With AML?

By: Kayci Reyer
Posted: Monday, May 18, 2020

The addition of the BCL2 inhibitor venetoclax to fludarabine, idarubicin, and filgrastim (FLAG-IDA) induction/consolidation therapy resulted in clinically significant activity in patients with both newly diagnosed or resistant acute myeloid leukemia (AML), according to research published in Blood and presented at the 2019 American Society of Hematology Annual Meeting& Exposition in Orlando (Abstract 176). However, Iman Aboudalle, MD, of the American University of Beirut, and colleagues noted that longer follow-up is needed to determine whether this therapeutic approach offers a long-term survival benefit.

The study included 34 patients, 16 of whom were enrolled in phase Ib and 18 of whom were enrolled in phase II of the trial. A total of 23 participants had relapsed or refractory AML, and 11 had newly diagnosed disease. Participants underwent FLAG-IDA induction and consolidation plus daily oral venetoclax for a median of two cycles.

Among the relapsed/refractory group, 17 (74%) achieved a complete response with or without incomplete hematologic recovery, with 12 patients (52%) becoming minimal residual disease–negative. Of the responding patients, nine continued on to receive allogeneic hematopoietic stem cell transplantation, three experienced a relapse, three died after achieving a complete response, and two were still undergoing study treatment. At a median follow-up of 5 months, overall survival was 7.1 months, and the duration of response had not been reached.

Of the 11 patients with newly diagnosed AML, 10 became minimal residual disease–negative, with 9 achieving a complete response and 1 achieving a complete response with partial hematologic recovery. A total of seven patients continue to undergo study treatment, whereas three patients moved on to allogeneic hematopoietic stem cell transplantation. Neither overall survival nor duration of response were reached.

Disclosure: For full disclosures of the study authors, visit ashpublications.org.



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