FLAG-Ida plus venetoclax induces high MRD-negativity rates in AML

Treatment led to high measurable residual disease-negativity rates in European LeukaemiaNet subgroups for newly-diagnosed acute myeloid leukaemia.

Participants with TP53 wild-type disease hinted at better response

Treatment with fludarabine plus cytarabine, idarubicin and granulocyte colony-stimulating factor (FLAG-Ida) chemotherapy plus venetoclax led to high measurable residual disease (MRD)-negativity rates across the European LeukaemiaNet (ELN) subgroups in participants with newly diagnosed acute myeloid leukaemia (AML).

The current phase 2 trial (NCT03214562) assessed the efficacy and safety of FLAG-Ida plus venetoclax in 127 participants with newly diagnosed (n=68) or relapsed/refractory (n=59) AML. The primary outcome was the objective response rate (ORR) defined by the ELN. Dr Wei-Ying Jen (MD Anderson Cancer Center, TX, USA) presented the results1.

In the participants with newly diagnosed disease, the ORR was 99% and MRD-negativity (10-4) was reported in 89%. These findings were consistent across ELN risk groups. The 2-year overall survival (OS) rate was 75%. Notably, those who received stem cell transplantation in their first clinical remission had a survival benefit over those who did not proceed to stem cell transplantation. In contrast, the ORR was 70% in participants with RR AML and the 2-year OS rate was 40% in this subgroup. “Participants with TP53 wild-type disease appeared to respond better to this therapy,” added Dr Jen.

As for safety, infections were the most common adverse events. Infections of grade 3 or higher occurred in 80% of the participants, whereas gastrointestinal toxicity or bleeding was documented in 16% and 7%, respectively.

In conclusion, FLAG-Ida plus venetoclax was associated with high MRD-negativity rates in newly diagnosed participants with AML. It also appeared to be an efficacious salvage treatment for participants with RR AML, especially those with TP53 wild-type disease.

Medical writing support was provided by Robert van den Heuvel.

  1. Jen W-Y, et al. FLAG-IDA + venetoclax in newly diagnosed or relapsed/refractory AML. Abstract #S136, EHA congress 2024, 13–16 June, Madrid, Spain.