Dr Marvin-Peek on the Significance of Efficacy Data for Azacitidine/Ivosidenib/Venetoclax in IDH1-Mutated AML

“CRc rates for [azacitidine/ivosidenib/venetoclax] have increased to 93% and to 95% or ORR [IDH1-Mutated AML.”

Jennifer Marvin-Peek, MD, a medical oncology fellow at the University of Texas MD Anderson Cancer Center discussed data for azacitidine, venetoclax (Venclexta), and ivosidenib (Tibsovo) in IDH1-mutated acute myeloid leukemia (AML) from a phase 1b/2 trial (NCT03471260)presented at the 2026 EHA Congress. Marvin-Peek began by discussing both current FDA approved frontline regimens for patients with IDH1-mutated AML. She noted that current data shows that between half and two-thirds of patients currently respond to each of those approved regimens. While acknowledging the promise of each of the currently approved regimen, Marvin-Peek pointed out that these data were not universal and able to be improved upon with other treatment combinations.

Among evaluable patients in the trial (n = 40), overall response rates (ORR) with azacitidine, plus venetoclax and ivosidenib was 95%. Moreover, composite complete response (CRc) rates for these patients were 93%. The best responses in these patients included CR (60%), CR with partial hematologic recovery (CRh; 18%), CR with incomplete count recovery (CRi; 15%), morphologic leukemia-free state (MLFS; 2.5%), and no response (5%). Additionally, a minimal residual disease (MRD) analysis by flow cytometry with a limit of detection of less than 0.1% showed that 91% of patients who were evaluable (n = 34) were MRD-negative.

Among patients with non-treated secondary AML (n = 33), CRc rates were 97%, with CR, CRh, CRi, MLFS, and NR occurring at the respective rates of 64%, 15%, 18%, 0%, and 3%.

Marvin-Peek also mentioned that data for median overall survival (OS) among these patients was not reached. Although, the 3-year OS rate for these patients was 79%, she said. Ultimately, Marvin-Peek concluded by pointing out that these data that were presented at the conference show encouraging outcomes for patients.