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EHA 2025 | Real-world safety & outcomes with gemtuzumab ozogamicin and 7+3 in patients with newly diagnosed AML
In this interview, Elizabeth Herrity, DNP, University Health Network, Toronto, Canada, presents the findings from a retrospective study investigating the real-world utilization, safety, and clinical outcomes of gemtuzumab ozogamicin in combination with intensive chemotherapy (7+3) in patients with newly diagnosed acute myeloid leukemia (AML). Although an encouraging composite complete remission (CRc) rate of 89% was observed, five treatment-related deaths occurred in this cohort of patients, highlighting the importance of exploring strategies to mitigate treatment-related complications with this therapeutic approach. This interview took place at the 30th Congress of the European Hematology Association (EHA) in Milan, Italy.
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Transcript
Yeah, so this work was a retrospective study looking at 62 patients with largely intermediate and favorable risk AML that received gemtuzumab ozogamicin in combination with 7 + 3 or daunorubicin and cytarabine and kind of following them over time to see not only how did they respond to therapy but what sort of adverse events they may have had as a result of therapy...
Yeah, so this work was a retrospective study looking at 62 patients with largely intermediate and favorable risk AML that received gemtuzumab ozogamicin in combination with 7 + 3 or daunorubicin and cytarabine and kind of following them over time to see not only how did they respond to therapy but what sort of adverse events they may have had as a result of therapy.
The findings were really that our composite CR rate was about 89%, so there was good response to therapy. However, we did see five treatment-related deaths during induction, of which three were suspected to be related to VOD in combination with some abdominal bleeding. The others were acute hypoxic respiratory failure from pneumonia and another I believe was intracranial hemorrhage.
You know I think this work is important to know how patients that are typically intermediate and favorable risk tolerate really toxic therapies. It’s really good to get them into remission and keep them in remission. It’s very impactful but you know we need to just make sure the benefits of therapy really outweigh some of the risks and these patients should theoretically do quite well. So it’s important to study and make sure we’re getting the same results in the real world use of therapy.
I think because there were not very many relapses in our patients, the most important thing to do would really work towards how do we mitigate the adverse complications that we see like serious bleeding and liver toxicity and VOD and really kind of exploring that avenue and how can we make gemtuzumab more tolerable so we can keep intermediate favorable risk patients in remission.
So the next steps for this study is really to collect a control cohort of patients that received 7 + 3 that were intermediate and favorable risk so that we have kind of compiled real-world evidence where we can set up propensities for matching of patients who received gemtuzumab with their 7 + 3 and those that didn’t and kind of look at how outcomes differed in terms of both response but also adverse events.
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