“Although the biology of acute myeloid leukemia (AML) has been well studied, the prognosis of this deadly disease remains frustratingly low, with 5-year survival rates of 66% in children and 24% in adults.” For patients who receive intensive chemotherapy, relapse (and refractory disease) is often common. Better tolerated and more effective therapies are needed.

Venetoclax is a new drug that has shown promising results. Yet, there are patients who have become resistant to this therapy. Recent studies have demonstrated that voruciclib has been effective as a stand-alone medication and in combination with venetoclax for relapsed and refractory AML patients.

“Clinical activity was observed with voruciclib alone and at the initial dose level in combination with venetoclax. The early results were consistent with the hypothesized ability of voruciclib to inhibit MCL-1 through CDK9 inhibition, which is thought to address a common venetoclax resistance mechanism.”

Voruciclib is orally administered and is generally well tolerated with no significant myelosuppression (a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets. It is a side effect of some cancer treatments). “Results further demonstrated encouraging clinical activity in heavily pretreated patients administered voruciclib alone and at the initial dose level in combination with venetoclax.” 

This Phase 1 study is currently recruiting. (Contact: MEI, 858-369-7100, patients@meipharma.com) 

Part 1 of the Study: Voruciclib as a Monotherapy

• Patients are dosed daily at medication intervals (50 mg, 100 mg, 200 mg)
• All participants have had a median of 3 prior therapies
• Disease control rate (DCR) of 50% over a 72 day period
• Common side effects have been diarrhea, nausea and fatigue

Part 2 of the Study: Voruciclib and Venetoclax

• 50 mg of voruciclib every other day plus venetoclax
• No bone marrow toxicities have been observed
• All participants have had a median of 3 prior therapies
• DCR of 50% has been achieved during a 28 day cycle.

Study results show the effectiveness of using voruciclib to treat relapsed and refractory AML.