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The results from the VIALE-A trial, which has demonstrated that previously-untreated patients with acute myeloid leukemia ( AML ) who were ineligible for intensive chemotherapy treated with Venetoclax ( Venclyxto ) plus Azacitidine achieved a 34% reduction in the risk of death compared to Azacitidine in combination with placebo ( hazard ratio, HR=0.66 [ 95% CI 0.52-0.85 ], p=0.001 ), were announced at Virtual 25th European Hematology Association ( EHA ) Annual Congress.

VIALE-A trial was designed to evaluate the efficacy and safety of Venetoclax in combination with Azacitidine ( n=286 ) compared with placebo in combination with Azacitidine ( n=145 ).

Patients receiving the Venetoclax combination have achieved improved median overall survival ( OS ) ( 14.7 months versus 9.6 months in the placebo arm ), and 66.4% of patients treated with Venetoclax plus Azacitidine had a composite complete remission ( CR + CRi ) compared to 28.3% treated with Azacitidine plus placebo.

The randomized, double-blind, placebo-controlled, phase 3 VIALE-A trial evaluated the efficacy and safety of Venetoclax in combination with Azacitidine in patients with acute myeloid leukemia who are ineligible for standard induction therapy.
The study met its primary endpoints of statistically significant improvement of overall survival and composite complete remission rate ( CR + CRi ).

The study also met secondary endpoints, with the Venetoclax combination arm resulting in a complete response ( CR ) rate of 36.7%, a CR with partial hematologic recovery ( CRh ) rate of 64.7% and a composite complete remission rate ( CR + CRi ) of 66.4%, compared to 17.9% CR, 22.8% CRh and 28.3% CR + CRi in the placebo arm.

The observed safety profile is generally consistent with the known safety profiles of Venetoclax combined with Azacitidine and the known safety profiles of the two medications alone.
The most common ( occurring in 10% of patients or more ) grade 3/4 adverse events in patients receiving Venetoclax plus Azacitidine were thrombocytopenia ( 45% ), neutropenia ( 42% ), febrile neutropenia ( 42% ), anemia ( 26% ), leukopenia ( 21% ), pneumonia ( 20% ) and hypokalemia ( 11% ).

Venetoclax is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 ( BCL-2 ) protein.
In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. Venetoclax targets the BCL-2 protein and works to help restore the process of apoptosis.

Acute myeloid leukemia is the most common acute leukemia in the world. An estimated 160,000 people are currently living with the disease globally with an incidence rate of 103 new cases per 100,000 people.
It is also among the most difficult blood cancers to treat. Despite advances in available therapies and care, the five-year survival rate for patients diagnosed with AML remains approximately 28 percent.
Acute myeloid leukemia typically worsens quickly, and due to age and comorbidities, not all patients can tolerate intensive induction chemotherapy. ( Xagena )

Source: Abbvie, 2020

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