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Australian researchers have opened a new clinical trial offering an innovative and promising new treatment combination for patients with transfusion dependent Myelodysplastic Syndromes (MDS), a form of blood cancer.

New Clinical Trial Explores Innovative Treatment for Transfusion-Dependent MDS

The MDS05/D3 MESSAGE trial, led by the Australasian Leukaemia & Lymphoma Group (ALLG), is evaluating the effectiveness of a new therapeutic combination of Australian discovered targeted drug amsulostat (SNT-5505) with hypomethylating agent ASTX727, aiming to improve survival outcomes and reduce the treatment burden associated with this type of MDS.

Chief Investigator A/Prof Anoop Enjeti – MDS05 MESSAGE

“Transfusion dependent myelodysplasia has no approved treatments currently available for Australian patients. The ALLG MDS05 MESSAGE trial’s new treatment combination aims to improve survival rates and quality of life for patients with this type of MDS by reducing the reliance on regular blood transfusions. Another unique aspect will be the combination of 2 oral medications making this trial more accessible to patients,” said lead MDS05 researcher, Associate Professor Anoop Enjeti.

Reducing Transfusion Burden & Improving Outcomes for MDS Patients

Blood cancers are one of Australia’s most common cancers, with nearly 20,000 diagnoses and 6,000 deaths annually. Myelodysplastic Syndromes, or MDS, are a form of blood cancer where patient’s bone marrow fails to produce enough healthy blood cells, causing bone marrow failure. In transfusion dependent MDS, patients experience dangerously low blood counts and require regular, fortnightly blood transfusions to manage their disease. This high treatment burden greatly impacts both quality of life for MDS patients and places a heavy burden on blood transfusion supply.

 

Unfortunately, patients with this type of MDS also experience far worse outcomes, with a 5-year survival rate of just 37.3%. They also face a high risk of progression from MDS to acute myeloid leukaemia (AML), an aggressive and often fatal blood cancer.

 

The ALLG MDS05/D3 MESSAGE is a phase 2 clinical trial evaluating the combination treatment of amsulostat and ASTX727 in patients with low and intermediate risk MDS. The multi-centre study will open at 10 hospitals across Australia, with up to 30 patients eligible to access this new, innovative treatment.

 

The ALLG MDS05/D3 MESSAGE trial will be conducted over 4 years, with the new treatment combination aiming to reduce the reliance on fortnightly blood transfusions required for these MDS patients, addressing a high unmet treatment need.

 

“Reducing the amount of blood transfusions is not only a huge benefit to these MDS patients but also reduces the significant burden this treatment causes to the healthcare system. Australian blood banks are facing an ever-increasing demand for red blood cells alongside a shrinking donor pool. By replacing blood transfusions with a new, effective treatment regimen, we can alleviate the burden on the system,” said A/Prof Enjeti.

 

“One of the inspirations for this study came from some groundbreaking pre-clinical work recently conducted by Heidelberg University that showed a significant increase in red blood cell production when the Syntara drug, amsulostat, was added to a hypomethylating agent that is commonly used in high risk MDS patients. Amsulostat has since been shown to be safe and well tolerated when used in patients with another type of haematological cancer, myelofibrosis, for up to 12 months so we are excited about the potential it might hold for patients with MDS who have very few treatment options,” said A/Prof Enjeti

ALLG Chief Executive Officer, Delaine Smith, said, “The ALLG is the only collaborative blood cancer clinical trial group in Australasia, conducting clinical trials into MDS, AML and other leukaemias, lymphomas and myeloma.  Our independent, clinician-led network enables us to conduct research into all areas of blood cancers, including rarer cancers and areas of high unmet need. We’re excited to launch the MESSAGE clinical trial to improve the outcomes and quality of life for transfusion-dependant MDS patients and delighted to work with Syntara whose original research underpins this new treatment concept.”

The ALLG MDS05/D3 MESSAGE clinical has been funded by the Australian Government’s Medical Research Future Fund as well as Industry partners Syntara and Taiho.

About the ALLG: Australia’s Not For Profit Leader in Blood Cancer Clinical Trials

The Australasian Leukaemia & Lymphoma Group (ALLG) is a not-for-profit organisation dedicated to improving outcomes for people living with blood cancers. Through our network of clinician researchers, scientists and hospitals across Australia and New Zealand, the ALLG conducts high-quality, independent clinical trials that drive new treatment advances and expand options for patients with limited therapies available to deliver Better treatments…Better lives.