Dr. DiNardo on Timing and Impact of Response to Venetoclax Combinations in AML

Courtney DiNardo, MD, MSCE, clinical researcher in the Department of Leukemia of the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses findings from a pooled analysis examining venetoclax (Venclexta) combination treatment in acute myeloid leukemia (AML).

A few important findings were identified in the pooled analysis of 2 open-label trials (NCT02203773 and NCT02287233), where investigators assessed the timing and impact of response, the likelihood of response, and patient characteristics associated to response to venetoclax when administered in combination with hypomethylating agents or low-dose cytarabine in older patients with newly diagnosed AML, says DiNardo.

To start off, investigators discovered that approximately 40% of the patients who responded after the first 2 cycles of treatment achieved an morphological leukemia—free state (MLFS) within those cycles, adds DiNardo.

Moreover, the type of AML, whether it was de novo or secondary, also impacted the likelihood of response in subsequent cycles. Patients with secondary AML were less likely to respond after 2 cycles of treatment, explains DiNardo.

In this analysis, the Classification and Regression Tree (CART) model was utilized to examine different patient characteristics predict outcomes. In general, patients who achieved a MLFS or had newly diagnosed de novo disease had a reasonable likelihood of responding in subsequent cycles of treatment, says DiNardo.

Investigators also set out to understand whether a response occurring later on is not as strong or as durable as one that is achieved earlier on. Results showed an impressive median overall survival (OS) of over 18 months in both arms, regardless of when the response was achieved, adds DiNardo.

The 1-year estimated OS rate was 75% and an estimated 2-year OS of approximately 50%. These data indicate that if patients obtained remission after the third or fourth cycle of treatment, it was still an important end point, concludes DiNardo.