Promising ENHANCE Study For HR-MDS Pulled in Phase 3

One week ago, on July 21st 2023, Gilead announced in a press release that they would be discontinuing their Phase 3 ENHANCE study looking at magrolimab plus azacitidine in High-Risk MDS (HR-MDS) patients. This study has been watched closely by the MDS community as it was set to introduce the first new class of treatments, monoclonal antibodies, that MDS patients would have seen in almost 20 years. 

What Are Monoclonal Antibodies?

Antigens are foreign substances that have entered the body, like a virus, bacteria, allergen, or other toxins. Antibodies are proteins created by the immune system whose goals are to find and stick to a specific antigen, signaling for the rest of the immune system to come and attack the antigen. This is one of our body's ways of fighting off illness. 

Monoclonal antibodies are antibodies that are created in a lab by researchers who have a specific antigen they want to target. Once a target antigen has been identified, researchers can produce large quantities of the antibody specifically created to stick to the antigen. The monoclonal antibodies can then be given to a patient who has the target antigen to help their immune system recognize and attack those cells more effectively. 

What is Magrolimab?

Magrolimab is a first-in-class monoclonal antibody. Magrolimab’s target is CD47, an antigen who is responsible for the “don’t eat me” signal on many different types of cells. This signal blocks the immune system from targeting those cells. 

Research has shown that CD47 is often overexpressed on cancerous cells, making it hard for the immune system to recognize the cancerous cells as “bad” or abnormal. Magrolimab’s goal is to find all CD47 antigens and put big, neon, “eat this one!” signs on all of them, helping the immune system better control and fight cancer.

Why Pull The ENHANCE Study In MDS?

The ENHANCE study had two primary endpoints:

• Complete Response
• Overall Survival

In their press release, Gilead revealed that in a planned analysis of the trial data, it was determined that magrolimab was not effective at helping reach the primary endpoints for HR-MDS patients like researchers had initially hoped it would.

What’s Next For HR-MDS Treatment?

As reiterated by Merdad Parsey, Chief Medical Officer at Gilead Sciences, “while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years."

Trial failures are always disappointing. But, it’s important to remember that every trial gives us new information, regardless of its success or failure. Failed trials help us to narrow down areas to focus our research on and study further, or show us that we need to try it again from a different angle. 

While the future of monoclonal antibodies isn’t clear in MDS, the science behind them is very promising and has the potential to change the way MDS is treated in big ways. Magrolimab continues to be investigated for use in other cancers ranging from solid tumors to acute myeloid leukemia (AML), a cancer very similar to MDS. I wouldn’t count monoclonal antibodies out for MDS just yet.

We at HealthTree are eager to see what comes next for the treatment of HR-MDS and will keep you informed about other exciting trials currently ongoing for MDS patients. 

Related MDS Resources On Clinical Trials:

MDS Clinical Trial Drugs Explained: Selinexor  Sabatolimab 
HealthTree Clinical Trial Finder: Interested in joining a clinical trial? Use our clinical trial finder to see what MDS trials you may be eligible to join! 
Specialist Directory: Want to find an MDS specialist to help you navigate the challenges of treating MDS? Use our specialist directory to find a specialist near you!