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ASH 2024 | Studying escalating doses of venetoclax with intensive chemo & induction in previously untreated AML
Anand Patel, MD, University of Chicago Medical Center, Chicago, IL, comments on the final results of a Phase I study combining escalating doses of venetoclax with a standard regimen of daunorubicin/cytarabine induction and high-dose cytarabine consolidation in previously untreated adults with acute myeloid leukemia (AML). Dr Patel highlights the encouraging results of the trial, with around 90% of patients achieving a complete remission (CR), many of which were measurable residual disease (MRD)-negative. These findings suggest that this combination is well-tolerated and may lead to deeper responses to potentially cure patients without the need for allogeneic transplantation (alloSCT). This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
This is a study that I’ve had the pleasure of participating in led by my colleague Dr Rich Stone at the Dana-Farber. So this is a study looking at combining venetoclax with the standard induction regimen that we use here in the United States, 7 plus 3, and then subsequently including it with the standard consolidation that we use, high-dose cytarabine. So the initial dose-finding phase found that a 400 milligram dose of venetoclax given for approximately 11 days combined with intensive chemotherapy and induction was safe and quite efficacious...
This is a study that I’ve had the pleasure of participating in led by my colleague Dr Rich Stone at the Dana-Farber. So this is a study looking at combining venetoclax with the standard induction regimen that we use here in the United States, 7 plus 3, and then subsequently including it with the standard consolidation that we use, high-dose cytarabine. So the initial dose-finding phase found that a 400 milligram dose of venetoclax given for approximately 11 days combined with intensive chemotherapy and induction was safe and quite efficacious. So MRD negative complete remissions were seen in 90% or so of patients.
And then the second part was identifying the appropriate dose of venetoclax to be given with consolidation. So what we found there was a 400 milligram dose of venetoclax again given for approximately eight days in combination with high dose cytarabine. Ultimately approximately 43 patients have been treated on study with a CR rate of 91% or so, and the vast majority of those being MRD negative CRs.
One thing to note is that this is a study that was predominantly carried out in patients under the age of 60. There were initially patients enrolled above the age of 60. We did see some early toxicity there, which then led to an amendment of the age range that we focused on.
So with that in mind, I think this furthers evidence showing that not only is it safe to combine venetoclax with 7 and 3 followed by high-dose consolidation. But we may be seeing deep responses beyond just morphologic remissions and truly being able to eradicate MRD. I think this has more and more clinical relevance as we’re finding that eradication of MRD early on, whether it be things like NPM1, may ultimately allow for patients to be cured without a consolidative allogeneic transplant.
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Disclosures
Sumitomo: Research Funding; Bristol Myers Squibb: Honoraria; Sobi: Honoraria; AbbVie: Honoraria; Pfizer: Research Funding; Kronos Bio: Research Funding.
