Trial Results of FLAG-IDA and Venetoclax for AML

Acute myeloid leukemia (AML) is often treated with intensive chemotherapy and targeted therapy. The current treatment for newly diagnosed AML and relapsed/refractory AML is a chemotherapy regimen with cytarabine and an anthracycline.  Researchers are currently studying ways to improve outcomes by adding medications to this treatment 

At the 2025 European Hematology Association conference, researchers presented the results from a phase 2 ongoing study of the FLAG-IDA chemotherapy combination with venetoclax (Venclexta, AbbVie). FLAG-IDA is a chemotherapy regimen that includes fludarabine, cytarabine, idarubicin, and filgrastim. 

Study design

Patients with  newly diagnosed or relapsed/refractory AML who had never received venetoclax were eligible to enroll in this study. Participants had to be 18 or older with adequate heart, kidney, and liver function. Patients with leukemia that had spread to the brain or spinal fluid were not included.

As of January 2024, there were 134 patients enrolled in the study, with 68 who had newly diagnosed AML and 59 with relapsed/refractory AML. The median age was 45, meaning half of the participants were younger than 45 and half were older. 

How did FLAG-IDA and venetoclax work to treat newly diagnosed AML?

All of the 68 newly diagnosed patients responded to treatment, and 96% reached complete remission (CR). Of these, 89% had no measurable residual disease (MRD). This means highly sensitive tests could not detect any leukemia cells in the body.

The two-year overall survival was 75%. More than half of the patients (57%) received a stem cell transplant. Patients who had a transplant in their first remission lived longer than those who did not. There were four patients in the study with newly diagnosed AML who had a TP53 mutation. This mutation is linked to more aggressive disease. All four of these patients had a complete response, but the duration of response was only 8.2 months. 

How did FLAG-IDA and venetoclax work to treat relapsed or refractory AML?

Among the 59 patients included with relapsed/refractory AML, 70% responded to treatment, with 66% reaching complete remission or similar outcomes. Of those, 79% were MRD negative.

The median overall survival in this group was one year. However, patients whose disease had returned for the first time and who did not have TP53 mutations had a median survival of 34 months. 58% of patients in this group were able to receive a stem cell transplant in their second remission.

Side effects and safety of FLAG-IDA and venetoclax

The most common side effect was infection, which occurred in 80% of patients at a severe level (grade 3 or higher). Gastrointestinal problems and bleeding were less common. The timing for blood count recovery varied between cycles, with the first cycle generally recovering faster than later cycles. 

Early treatment-related deaths were rare. At 30 days after starting treatment, no patients had died. By 60 days, 3% had died, mostly due to disease progression after the FLAG-IDA and venetoclax combination did not control the AML.

FLAG-IDA and venetoclax helped patients with both newly diagnosed AML and relapsed and refractory AML

FLAG-IDA plus venetoclax led to high response rates in both newly diagnosed and relapsed/refractory AML. For newly diagnosed patients, especially those able to proceed to stem cell transplant, survival outcomes were strong across different risk groups. More research will clarify how this regimen compares to other standard options.

Keep reading more about treatment advancements and clinical trials with the HealthTree News Site. 

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Source: 

• FLAG-IDA + VENETOCLAX (VEN) IN NEWLY DIAGNOSED (ND) OR RELAPSED / REFRACTORY (RR) AML