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iwAL 2019 | ADCs for AML: gemtuzumab ozogamicin

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Naval Daver

Here, Naval Daver, MD, of the University of Texas MD Anderson Cancer Center, Houston, TX, discusses the use of gemtuzumab ozogamicin as an antibody-drug conjugate (ADC) for the treatment of acute myeloid leukemia (AML). This video was recorded at the International Workshop on Acute Leukemias (iwAL) 2019, held in Barcelona, Spain.

Transcript (edited for clarity):

Naval Daver, MD:  A number of antibody drug conjugates are now in development in acute myeloid leukemia. The first among these is a drug called gemtuzumab ozogamicin, also called Mylotarg. This is a CD33 antibody that’s conjugated to a bacterial toxin, calicheamicin. This drug is the first antibody drug conjugate that has been developed in acute leukemia, both in AML and ALL. And it’s been around for almost 15, 16 years now...

Naval Daver, MD:  A number of antibody drug conjugates are now in development in acute myeloid leukemia. The first among these is a drug called gemtuzumab ozogamicin, also called Mylotarg. This is a CD33 antibody that’s conjugated to a bacterial toxin, calicheamicin. This drug is the first antibody drug conjugate that has been developed in acute leukemia, both in AML and ALL. And it’s been around for almost 15, 16 years now. It was initially approved about a decade ago based on data from relapsed population, but there were some concerns about VOD and myelosuppression. So, a number of European and American groups evaluated lower doses and fractionated dosing of the gemtuzumab. And at the lower fractionated dosing, the gemtuzumab is much safer, better tolerated, lower VOD, and is effective.

Naval Daver, MD: The US FDA, about a year and a half ago re-approved gemtuzumab, specifically in two major settings, one is to be used in combination with induction chemo, either with the 3+7 or with other inductions like FLAG-Ida. And this is given upfront either once with FLAG-Ida or three times, day one, four, and seven, with the 3+7 induction. This was the alpha regimen.

Naval Daver, MD: In that setting, it does appear that the addition of gemtuzumab to the induction, whether it was 3+7 or FLAG-Ida, improved overall survival in all patients taken together. But most specifically, in patients who had core-binding factor inversion 16 (8;21) AML, and those who had intermediate cytogenetics.

Naval Daver, MD: So in the United States, we are frequently using the gemtuzumab, especially for core-binding factor AML. That sort of survival benefit is the most striking. There’s a 20% absolute survival benefit appears actually both on the FLAG-Ida and 3+7. And at MD Anderson, that’s our number one regimen for core binding factory using FLAG-Ida gemtuzumab.

Naval Daver, MD: In the intermediate groups, it’s improved and it’s used sometimes. Although we have other exciting drugs we’re exploring there. Such as FliD 3 inhibitors, IDH, venetoclax added to chemo. So gemtuzumab is not our first choice.

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