The mds Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the mds Hub cannot guarantee the accuracy of translated content. The mds and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View mds content recommended for you
Naval Daver
David SallmanOn September 15, 2020, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to magrolimab, a first-in-class anti-CD47 monoclonal antibody, to treat newly diagnosed patients with myelodysplastic syndromes (MDS).1
The macrophage immune checkpoint protein CD47 is a ‘do not eat me’ signal that facilitates immune evasion of malignant cells. Therefore, its blockade by magrolimab induces tumor phagocytosis and promotes the elimination of tumor cells. Additionally, CD47 has been reported to be overexpressed in myeloid malignancies, including acute myeloid leukemia (AML) and MDS.2
The FDA decision was based on the promising preliminary results from the phase Ib study of magrolimab in patients with intermediate to very high-risk MDS ineligible for intensive chemotherapy (5F9005, NCT03248479). These results were first presented at the 25th Congress of the European Hematology Association (EHA).
- A total of 30 (91%) from the 33 efficacy evaluable patients achieved an objective response, and after 6 months of follow-up, 91% of them continued in response.
- Moreover, the investigators reported that responses deepened over time, from 42% to 56% of complete responses in patients with ≥ 6 months follow-up.
- Regarding tolerability of the combination, safety was similar to the control arm (azacytidine alone). The most common treatment-related adverse events reported were anemia (44%), fatigue (18%), infusion reaction (18%), neutropenia (8%), and thrombocytopenia (5%). Of note, no patients discontinued due to an adverse event.3
The improved efficacy of the combination of magrolimab with azacytidine in untreated patients with intermediate to very high-risk MDS will be confirmed in the ongoing phase III, double-blind, placebo-controlled, randomized study (ENHANCE, NCT04313881).3
Listen below to the discussion between David Sallman (Moffitt Cancer Center, Tampa, US) and Naval Daver (MD Anderson Cancer Center, Houston, US) about the potential of magrolimab to treat patients with AML and MDS.
Can CD47 antibody therapy be safely used for AML and MDS?
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content