August 13, 2020
- Older patients with acute myeloid leukemia (AML) have a poor prognosis, even after treatment with a hypomethylating agent.
A hypomethylating agent or demethylating agent is a drug that inhibits DNA methylation.
- Azacitidine added to venetoclax had promising efficacy in a previous phase 1b study.
- This research randomly assigned previously untreated patients with confirmed AML to azacitidine plus either venetoclax or placebo.
- The patients were ineligible for standard induction therapy because of coexisting conditions, 75 years of age or older, or both.
- All patients received a standard dose of azacitidine.
- Venetoclax or matching placebo was administered orally, once daily, in 28-day cycles.
- The primary end point was overall survival.
- The intention-to-treat population included 431 patients.
- 286 patients were in the azacitidine-venetoclax group and 145 patients were in the azacitidine-placebo group.
- The median overall survival was 14.7 months in the azacitidine-venetoclax group.
- The median overall survival was 9.6 months in the control group.
- The incidence of complete remission and composite complete remission was higher with azacitidine-venetoclax than with the control regimen.
- Complete remission is the disappearance of signs and symptoms, while composite complete remission is a complete remission with incomplete hematologic recovery.
- Key adverse events included nausea of any grade, and grade 3 or higher thrombocytopenia, neutropenia, and febrile neutropenia.
Neutropenia occurs when you have too few neutrophils, a type of white blood cells.
- Infections of any grade occurred in 85% of the patients in the azacitidine-venetoclax group and 67% of those in the control group.
- Serious adverse events occurred in 83% of the patients in the azacitidine-venetoclax and 73% of those in the control group.
- The result shows that the overall survival was longer and the incidence of remission was higher among patients who received azacitidine plus venetoclax than among those who received azacitidine alone.
- The incidence of febrile neutropenia was higher in the venetoclax-azacitidine group than in the control group.
A Comparison of Azacitidine and Decitabine Activities in Acute Myeloid Leukemia Cell Lines
The Guardian of Anti-Apoptotic Proteins in Acute Myeloid Leukemia
U2AF1 Mutations in Chinese Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome
Keywords: what is Azacitidine, what is Venetoclax, treatment for Myeloid Leukemia, cancer treatment, cancer drugs, AML treatment, AML
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“Venclyxto EPAR”. European Medicines Agency (EMA). Retrieved 25 April2020. This article incorporates text from this source, which is in the public domain.