Magrolimab Shows Promise in MDS and AML

Naval G. Daver, MD, an associate professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, discusses the latest research on magrolimab, a CD47 monoclonal antibody, for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). 

Currently, there are 4 CD47 antibodies available in the clinic for these patient populations. According to Daver, magrolimab is the most advanced and obtains the most mature clinical data available.

Daver also examines the results from the prospective, phase 1 trial (NCT03248479) of single-agent magrolimab in the relapsed/refractory AML setting. These data have led to commencement of the phase 3 ENHANCE trial (NCT04313881) investigating the combination of magrolimab plus azacitidine (Vidaza) for patients with MDS.

Transcription:

0:08 | At this time, there are 4 different CD47 antibodies in clinic for AML and MDS. The one that has the most advanced clinical data, most mature so far, is a drug called magrolimab. This is a CD47 monoclonal antibody and it's been combined with azacitidine in the frontline setting and in a now completed a phase 1b study, which had 2 parts. One was for high-risk MDS patients, including intermediate, high, or very high IPSS patients. The other part was for TP53-mutated frontline AML.

0:40 | Overall, the data for the MDS patients was that we had 95 patients with this higher risk MDS and the response rate is encouraging, 75% with a true CR rate of about 33% or 34%. What's interesting is in the subsets that included TP53-mutated, which made up about 25 of those 95 patients, the median survival is quite promising at greater than 16 months. Historically, pretty much in any other study that we have seen in MDS TP53, the survival has been between 9 and 12 months.

1:11 | This is single arm, but this data looks quite promising. In the non-TP53 subgroup, the median survival has not been reached, with a median follow-up of about 18 months. Overall, it's a single-arm study, so it's hard to know for sure, but this data does look encouraging. This has led to a randomized phase 3 study now ongoing, called the ENHANCE study, which in fact just completed accrual a couple of weeks ago. We're hoping to start seeing some of the primary end point data early next year.