A trial of magrolimab with chemotherapy to treat acute myeloid leukaemia and myelodysplastic syndrome
Cancer type:
Status:
Phase:
This trial looked at an immunotherapy drug called magrolimab alone or with azacitidine for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS). Magrolimab is pronounced mah-grow-lih-mab.
It was for people with either:
- higher risk MDS who had not had treatment with chemotherapy or
immunotherapy 
or - AML who had not had treatment and were unable to have intensive
chemotherapy
The trial was open for people to join between 2015 and 2018. The team published the results for magrolimab with azacitidine in 2023.
More about this trial
Higher risk MDS can be difficult to treat. When this trial was done, the only way to get rid of it completely in the long term is to have a stem cell transplant using donor stem cells.
It can be more difficult to treat AML in people who:
- are older
- are less fit or able to do everyday activities (lower performance status)
- have certain genetic changes
We know from research that cancer cells have a large amount of a protein called CD47. This protein can stop the body’s immune system removing and destroying cancer cells.
Magrolimab is a type of immunotherapy called a monoclonal antibody. It works by blocking the signals of CD47 that stop the immune system from working.
We know that AML and MDS cells have a large number of CD47. And have shown that magrolimab can successfully treat AML.
Azacitidine is a type of chemotherapy drug. At the time of the trial, it was a for some people with AML and MDS. Laboratory studies had shown that azacitidine can help magrolimab to work better.
Everyone taking part had magrolimab and azacitidine.
The main aims of this trial were to find out:
- how well magrolimab and azacitidine worked for people with AML and MDS
- more about the side effects of treatment
Summary of results
This trial showed that magrolimab and azacitidine worked for some people with higher risk MDS or AML. And the side effects weren’t too bad.
Results
This was a phase 1b trial.
People taking part with MDS
95 people joined the trial and had magrolimab in cycles of treatment.
Everyone had intermediate risk, high risk, or very high risk MDS. And they had not had chemotherapy or immunotherapy before.
The average number of cycles of treatment was 6. And 4 people taking part were still having treatment at the end of the trial.
The researchers followed up the people taking part for 17.1 months on average.
31 people (33%) had no signs of their MDS. And 71 people (75%) had either no signs of their MDS, or their MDS had improved.
The researchers looked at the time between treatment and signs that the MDS was getting worse. They found that this was 11.6 months on average.
Other studies have shown that people in this position live, on average, around 10 to 19 months after treatment with just azacitidine.
34 people (36%) in this trial had a stem cell transplant after the trial treatment, with 26 of these people (77%) still alive after 2 years.
People taking part with AML
87 people joined the trial and had treatment with magrolimab and azacitidine in . This was everyone’s first treatment for their AML. They were not able to have intensive chemotherapy.
People had on average of 4 cycles of treatment. 86 people (99%) stopped having treatment before the end of the trial. This was for a number of reasons including side effects, the treatment not working or their AML getting worse.
72 out of the 87 people (83%) taking part had a fault (mutation) in the TP53 gene. This is a type of . Having this can make AML more difficult to treat. The study team specifically asked people with this gene change to take part.
The researchers followed up the people with TP53 gene changes for 8.9 months on average.
28 people had no signs of their AML after treatment.
This included 23 people with changes in the TP53 gene. There was then no sign of their AML for 7.6 months on average.
The trial team looked at how long people lived. They found it was, on average:
- 9.8 months for people with the TP53 gene change
- 18.9 months for people without the gene change
Other studies have shown that people with TP53 changes live, on average, between 4 to 7 months when they have treatment with intensive chemotherapy.
Side effects
Side effects in those with MDS
The trial team say the side effects were manageable for most people. The most common side effects were:
- constipation
- a drop in blood cells
- feeling sick
- diarrhoea
Some people had more serious side effects. The most common serious side effects are listed below.
- 23 people had a high temperature with low levels of
white blood cells (febrile neutropenia) - 9 people had
pneumonia - 8 people had low levels of red blood cells (
anaemia ) - 6 people had a bacterial infection
10 people stopped treatment due to side effects.
19 people (20%) died due to the MDS getting worse. And 8 people (around 8%) died from causes that may have been related to treatment.
Side effects in those with AML
The most common side effects were:
- constipation
- feeling sick
- diarrhoea
- a high temperature with low levels of
white blood cells (febrile neutropenia) - low levels of
platelets - tiredness (fatigue)
Some people had more serious side effects. The most common serious side effects are listed below.
- 23 people had a high temperature with low levels of white blood cells (febrile neutropenia)
- 11 people had pneumonia
- 6 people had a reaction while having one of the drugs
- 5 people had confusion
26 people stopped having magrolimab and 25 people stopped having azacitidine because of the side effects.
39 people (45%) died from their AML getting worse. And 18 people (21%) died from causes that may have been related to treatment.
Conclusion
The researchers say that magrolimab and azacitidine worked for some people with MDS or AML in this small study. The trial team suggest that further trials are done to find out more.
More detailed information
There is more information about this research in the references below.
Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.
Magrolimab in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes: Final Results of a Phase Ib Study
D A Sallman and others
Journal of Clinical Oncology, 2023. Volume 41, number 15.
Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results
N G Daver and others
Journal of Clinical Oncology, 2023. Volume 41, number 31.
Where this information comes from
We have based this summary on the information in the articles above. These have been reviewed by independent specialists () and published in medical journals. We have not analysed the data ourselves. As far as we are aware, the links we list above are active and the articles are free and available to view.
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How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Paresh Vyas
Supported by
Bloodwise
Experimental Cancer Medicine Centre (ECMC)
Forty Seven Inc
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
Stanford University
University of Oxford
California Institute for Regenerative Medicine (CIRM)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
