POSTER: AML-454 Real-World Use of Azacitidine (AZA) and Venetoclax (VEN) in Acute Myeloid Leukemia (AML) in Frontline and Relapse/Refractory (R/R) Settings: Multicenter Study From French AURAML Group
Maël HeibligEmmanuelle TavernierGaspar Aspas RequenaAmine BelhabriNatacha MauzAdrien ContejeanGian-Matteo PicaMartin CarréClément RocherClémence SantanaZofia Gross
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Elderly patients with acute myeloid leukemia (AML) have been found to clinically benefit from the combination of azacitidine (AZA) and venetoclax (VEN), although the safety and efficacy of the treatment in extremely elderly patients (age >85 years) have not been fully established. An 88-year-old woman diagnosed with AML was given a lower dose of AZA and VEN. She eventually developed grade 4 hypokalemia, necessitating treatment interruption. However, a lower dose of VEN was successfully continued in the subsequent cycle of treatment, resulting in complete remission. Hence, reduced AZA and VEN doses may be beneficial for extremely elderly AML patients.
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"CLO22-037: Tumor Lysis Syndrome and Infectious Complications During Induction With Venetoclax Combined With Azacitidine or Decitabine in Patients With Acute Myeloid Leukemia" published on 31 Mar 2022 by National Comprehensive Cancer Network.
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Older patients with acute myeloid leukemia (AML) have a dismal prognosis, even after treatment with a hypomethylating agent. Azacitidine added to venetoclax had promising efficacy in a previous phase 1b study.
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Acute Myeloid Leukemia: Acute Myeloid LeukemiaThe combination of venetoclax plus azacitidine shows positive results in acute myeloid leukemia (AML), according to a phase III clinical trial. The study demonstrated statistically significant improvement in the primary endpoints of overall survival (OS) and a composite complete remission rate. AML is known to be one of the most aggressive and difficult-to-treat blood cancers with a very low survival rate and few treatment options. Despite advances in available therapies and care, the 5-year survival rate for patients diagnosed with AML remains approximately 28 percent. AML typically worsens quickly, and due to age and comorbidities, not all patients are eligible to receive intensive chemotherapy. 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 the self-destruction process apoptosis. It targets the BCL-2 protein and works to help restore the process of apoptosis. The VIALE-A study evaluated the efficacy and safety of venetoclax in combination with azacitidine compared with placebo in combination with azacitidine. The trial enrolled 443 treatment-naive patients with AML, and randomized 433 patients in the double-blind, placebo-controlled phase III trial, including 287 patients who received venetoclax plus azacitidine and 146 patients who received placebo in combination with azacitidine. The study met its dual primary endpoints of OS and composite complete remission—complete remission (CR) plus complete remission with incomplete hematologic recovery (CRi)—for patients with previously untreated AML who were ineligible for intensive chemotherapy. At the recommendation of an independent data monitoring committee, and per the pre-specified interim analysis plan, due to positive efficacy results at the first interim analysis for OS, the trial results will be reported early. The data from the trial will be submitted to the FDA and global health authorities, and the results will be presented at a future medical meeting or published in a peer-reviewed journal. The observed safety profile was generally consistent with the known safety profile of venetoclax combined with azacitidine as observed in previous phase I/II studies and the known safety profiles of the two medications. Venetoclax can cause serious adverse effects, including tumor lysis syndrome, neutropenia, and infections. The most common adverse events of venetoclax include low white blood cell counts, low platelet counts, low red blood cell counts, diarrhea, nausea, upper respiratory tract infection, cough, and muscle and joint pain. Another Venetoclax Combination In November 2018, venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) received accelerated approval from the FDA for the treatment of newly diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy based on the phase I/II studies. In February 2020, researchers shared an update on the phase III VIALE-C study of venetoclax in combination with LDAC compared with LDAC in combination with placebo in 210 newly diagnosed patients with AML who were ineligible for intensive chemotherapy. After a median follow-up time of 12 months at the end of the planned primary analysis for both arms, the update did not demonstrate statistically significant improvement in the primary endpoint of OS. At the time of the primary analysis median OS was 7.2 months in the venetoclax arm (142 patients) and 4.1 months in the comparator arm (68 patients). However, the results show clinical activity of venetoclax in combination with LDAC. Treatment with the venetoclax combination showed a 25 percent reduction in the risk of death compared to LDAC with placebo. A post-hoc analysis after an additional 6 months of follow-up showed an increase in median OS of 8.4 months in the venetoclax plus LDAC arm and 4.1 months in the placebo plus LDAC arm. In addition, the composite complete remission rate (CR plus CRi) was higher in the venetoclax plus LDAC arm (47.6%) than in the placebo plus LDAC arm (13.2%). The safety profile of the combination was again consistent with the safety results reported in the phase I/II studies. Also consistent with prior studies in AML, the most frequently reported adverse events, irrespective of cause, were hematologic, including febrile neutropenia, neutropenia, thrombocytopenia, and anemia. Mark L. Fuerst is a contributing writer. Have Stories Delivered Directly to You Sign up for our free e-newsletter and receive email notifications when each issue becomes available and when other new content is posted online. New to HemOncTimes? Visit the publication's website at bit.ly/HemOncTimes.
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Refractory/relapsed acute myeloid leukemia is an advanced hematological malignancy with a poor prognosis in pediatric. The therapeutic options are limited and has been slow development of therapies for this age group. A combination of Venetoclax and Azacitidine therapy in newly diagnosed elderly patients with acute myeloid leukemia and refractory/relapsed disease has achieved impressive results. Whether similar results can be attained in pediatric patients is unknown. We present a case of adolescent girl with acute myeloid leukemia secondary to myelodysplastic syndrome, who was deemed unfit to undergo conventional chemotherapy and, was treated instead with the Venetoclax and Azacitidine.
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