Older patients with acute myeloid leukemia (AML) respond poorly to standard induction therapy. - A third cohort of BP1001 + decitabine is offered to refractory/relapsed AML patients who. Venetoclax is designed to kill leukemia cells by binding . venetoclax compare to intensive chemotherapy (IC) in patients who are "fit" or "unfit" for IC. Adults with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in an open-label, non-randomized, multicenter phase … The HMAs azacitidine and decitabine constitute the backbone of treatment of high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML) [29-32].Whether used as single agents or, more recently, in combination with venetoclax, HMAs have shown clinical activity in patients with primary, secondary, and relapsed/refractory AML [19,28,33]. Decitabine with venetoclax is an appropriate salvage therapy, comparable to intensive chemotherapy regimens, for younger adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), according to the results of a comparative study presented by Abhishek Maiti, MBBS, of the University of Texas MD Anderson Cancer Center in Houston, Texas, at the virtual 62nd American Society of . Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. VENCLEXTA® (venetoclax tablets) is indicated in combination with azacitidine, decitabine or low-dose cytarabine for newly diagnosed AML patients ineligible for intensive chemotherapy due to age or comorbidities. Patients with newly diagnosed acute myeloid leukemia (AML) who are aged 75 years or older or ineligible for intensive chemotherapy may have improved outcomes with a longer 10-day course of decitabine with venetoclax, according to research published in The Lancet Haematology.. Background: Venetoclax combined with hypomethylating agents is a new standard of care for newly diagnosed patients with acute myeloid leukaemia (AML) who are 75 years or older, or unfit for intensive chemotherapy. Dr. Chen reports on his research at ASH which found that preliminary results indicate venetoclax plus decitabine is an effective, lower-intensity regimen that is well tolerated for young adults with newly diagnosed adverse-risk AML, producing high rates of complete response, low rates of infections, and low rates of early death. All patients received 400 mg of daily venetoclax plus 10 days of 20 mg/m 2 of decitabine for 4 . Blood (2019) 133(1):7-17. doi: 10.1182/blood-2018-08-868752 - Refractory/relapsed AML patients will also be treated with BP1001 plus venetoclax plus. One treatment-naïve and one previously treated patient continued to receive decitabine and venetoclax with the addition of enasidenib from cycle 15 and 6, respectively. Ivosidenib, an IDH1 inhibitor, is approved for the treatment of relapsed/refractory (R/R) IDH1mut AML and newly diagnosed (ND) patients . Venetoclax (Venclexta®) + Decitabine (Dacogen®) is a Chemotherapy Regimen for Acute Myeloid Leukemia (AML) How does venetoclax + decitabine work? 1 The standard initial management for fitter patients with minimal comorbidities is intensive chemotherapy; older, less fit patients tolerate this poorly, resulting in limited effective treatment options. Blood 2019 ;133: 7 - 17 . Acute myeloid leukemia (AML) is a heterogeneous group of severe diseases with various molecular alterations, including chromosomal aberrations or genes mutations, that mainly occur after the sixth decade [].Venetoclax (VEN) belongs to a novel BH3-mimetic class of small molecules that selectively targets BCL-2, activating the apoptosis effectors BAX and BAK to drive . A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Outcomes of TP53-mutant acute myeloid leukemia with decitabine and venetoclax. Courtney DiNardo (MD Anderson Cancer . We report the results of the first combination of VEN+FLT3i+HMA from a prospective . Decitabine 20 mg/m 2 IV for 10 days with oral venetoclax 400 mg daily was administered for induction and decitabine (5 days) with daily venetoclax for consolidation. B-cell lymphoma 2 (BCL-2) overexpression is implicated in survival of AML cells and treatment resistance. We report the efficacy and safety of venetoclax plus decitabine-based treatment in heavily pre-treated relapsed or refractory acute myeloid leukaemia (RR-AML) in a real-world setting.There were 22 patients in this study and the median age was 47.5 (12-84) . We report safety and efficacy of venetoclax with decitabine or azacitidine from a large, multicenter, phase 1b dose-escalation and expansion study. Giving venetoclax in combination with decitabine may help treat patients with acute myeloid leukemia. Venetoclax combined with 10-day decitabine (DEC10-VEN) has a manageable safety profile and high activity in newly diagnosed AML and molecularly defined subsets of relapsed or refractory acute myeloid leukemia (AML) and relapsed or refractory disease in older patients. Among patients with IDH2 mut AML, 14 patients had treatment-naive AML and 11 patients had previously treated AML. DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, et al. Introduction. This analysis represents the longest-term follow-up for patients with acute myeloid leukemia (AML) treated with 400 mg of venetoclax plus azacitidine or decitabine. Maiti A, Qiao W, Sasaki K, et al. Older patients tend to have poor overall survival at 3 years (10-30%). Pharmacodynamic studies have suggested superiority of the longer 10-day regimen of decitabine that has shown promising results in patients with high-risk AML in phase 2 trials. Venetoclax-containing regimens in acute myeloid leukemia. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia Courtney D. DiNardo,1 Keith Pratz,2 Vinod Pullarkat,3,4 Brian A. Jonas,5 Martha Arellano,6 Pamela S. Becker,7,8 Olga Frankfurt,9 DiNardo CD, Pratz K, Pullarkat V, et al. We conducted a single-center, propensity-adjusted retrospective cohort study to compare composite complete remission (CCR) … DiNardo, C. D. et al. Responses initially recorded were complete response (CR), CR with incomplete hematologic . Acute myeloid leukemia (AML) is a heterogeneous group of severe diseases with various molecular alterations, including chromosomal aberrations or genes mutations, that mainly occur after the sixth decade [].Venetoclax (VEN) belongs to a novel BH3-mimetic class of small molecules that selectively targets BCL-2, activating the apoptosis effectors BAX and BAK to drive . Cancer. Venetoclax with decitabine or azacitidine for AML. DOI: 10.1002/cncr.33689; DiNardo C, Maiti A, Rausch C, et al. Day 4 and beyond (28-day cycle) In combination with azacitidine or decitabine: Take 400 mg of VENCLEXTA. In the February 2018 issue of Lancet Oncology, Courtney D. DiNardo from The University Texas MD Anderson Cancer Center, Houston, TX, and colleagues reported data from a dual-stage, non-randomized phase Ib study (NCT02203773), which is assessing the safety and preliminary efficacy of venetoclax (VEN), a BCL2 inhibitor, in combination with decitabine (DEC) or azacitidine (AZA) in previously . We compared outcomes of older patients with newly diagnosed AML receiving 10-day decitabine with venetoclax (DEC10-VEN) vs IC. Crossref decitabine. Drugs used in chemotherapy, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by . For New AML, 10-Day Decitabine-Venetoclax Combo Found Effective. We conducted a single-center, propensity-adjusted retrospective cohort study to compare composite complete remission (CCR) … Mechanisms of action. September 2018, a new bone marrow aspiration after 2 cycles of decitabine and 93 days of venetoclax was done: no blast cells in the bone marrow were documented, molecular markers persisted negative, chimerism improved to 95% of donor cells. VENCLEXTA® (venetoclax tablets) for Acute Myeloid Leukemia (AML) VENCLEXTA is a prescription medicine used in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with. Venetoclax with decitabine versus intensive chemotherapy in acute myeloid leukemia: A propensity score matched analysis stratified by risk of treatment-related . Study M14-358 (ClinicalTrials.gov identifier NCT02203773) assessed venetoclax in combination with azacitidine (n = 67) or decitabine (n = 13) in newly diagnosed patients . Introduction. Patients who had relapsed after allogeneic transplant were excluded. Venetoclax + decitabine for adverse-risk AML in young adults 3. Presented at the 2016 American Society of Clinical Oncology Annual Meeting, June 6, 2016; Chicago, IL. Decitabine belongs to a class of anti-cancer drugs known as DNA methyltransferase (DNMT) inhibitors, which change how diseased cells in the blood and bone marrow grow and multiply. CAS Article Google Scholar Future larger and randomised studies are needed to clarify activity in high-risk subsets. NORTH CHICAGO, Ill., May 25, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has approved VENCLYXTO ® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. newly diagnosed AML who are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. Patients in the venetoclax plus HMA trial were treated with 400 mg of venetoclax daily and coadministered either 20 mg/m 2 of decitabine on days 1-5 or 75 mg/m 2 of azacitidine on days 1-7 Older patients with acute myeloid leukemia (AML) respond poorly to standard induction therapy. Treatment with a regimen of venetoclax and 10 days of decitabine resulted in a median overall survival of 18 months in adults with newly diagnosed acute myeloid leukemia (AML), with rates of neutropenia, infection and 30-day mortality that were "comparable" to those seen with . OR. We compared outcomes of older patients with newly diagnosed AML receiving 10-day decitabine with venetoclax (DEC10-VEN) vs IC. Venetoclax with 10-day decitabine has a manageable safety profile and showed high activity in newly diagnosed AML and molecularly defined subsets of relapsed or refractory AML. However, suboptimal responses have been observed in fit patients who are considered 'adverse-risk' compared with . VENCLEXTA is a prescription medicine used in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or; have other medical conditions that prevent the use of standard chemotherapy. To determine the overall response rate (ORR) of venetoclax in combination with 10-day decitabine in patients with refractory/relapsed acute myeloid leukemia (AML); elderly (> 60 year old) patients with newly diagnosed AML not eligible for intensive chemotherapy; patients with high-risk myelodysplastic syndrome (MDS) with bone marrow blasts between 10% and 20%, relapsed or . We report safety and efficacy of venetoclax with decitabine or azacitidine from a large, multicenter, phase 1b dose-escalation and expansion study. Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ≥ 65 years ineligible for standard induction therapy. DEC10-VEN consisted of daily venetoclax with decitabine 20 mg/m 2 for 10 days for induction and decitabine for 5 days as consolidation. Patients with newly diagnosed acute myeloid leukemia (AML) who are aged 75 years or older or ineligible for intensive chemotherapy may have improved outcomes with a longer 10-day course of decitabine with venetoclax, according to research published in The Lancet Haematology.. Venetoclax in combination with hypomethylating agents (HMAs) or low-dose cytarabine (LDAC) has demonstrated exceptional activity in elderly and unfit patients with newly diagnosed acute myeloid leukemia (AML). We compared outcomes of older patients with newly diagnosed AML receiving 10-day decitabine with venetoclax (DEC10-VEN) vs IC. This analysis represents the longest-term follow-up for patients with acute myeloid leukemia (AML) treated with 400 mg of venetoclax plus azacitidine or decitabine. By: Cordi Craig Posted: Tuesday, February 9, 2021. Pollyea DA, Dinardo CD, Thirman MJ, et al. Background:FLT3 mut confers higher risk of relapse and inferior overall survival (OS) in acute myeloid leukemia (AML). Venetoclax with 10-day decitabine has a manageable safety profile and showed high activity in newly diagnosed AML and molecularly defined subsets of relapsed or refractory AML. To determine the overall response rate (ORR) of venetoclax in combination with 10-day decitabine in patients with refractory/relapsed acute myeloid leukemia (AML); elderly (> 60 year old) patients with newly diagnosed AML not eligible for intensive chemotherapy; patients with high-risk myelodysplastic syndrome (MDS) with bone marrow blasts between 10% and 20%, relapsed or . Venetoclax, an oral selective inhibitor of the antiapoptotic protein BCL-2, shows encouraging anticancer activity and tolerable safety in older patients with acute myeloid leukaemia (AML) who are unfit for traditional chemotherapy, according to new research. Introduction. 7 In our cohort, outcomes in treatment naïve IDH1 mut AML appeared . 1. Venetoclax was not interrupted during hospitalization but the third cycle of decitabine was postponed. However, preclinical data suggests that TP53 . are venetoclax resistant or intolerant, or not considered by the . We report safety and efficacy of venetoclax with decitabine or azacitidine from a large, multicente … Blood 133 , 7-17 (2019). See full safety and Prescribing Info for more details Among those patients, 8 (23%) had a single mutation, 15 (43%) had multiple mutations, and 12 (34%) had both a mutation and a deletion. In young adults with newly diagnosed adverse-risk AML, venetoclax plus decitabine was associated with a composite CR rate of 76% and in a historical comparison showed a better efficacy and safety profile than cytarabine/idarubicin. B-cell lymphoma 2 (BCL-2) overexpression is implicated in survival of AML cells and treatment resistance. The combination of 10-day decitabine with venetoclax (Venclexta) elicited responses and was found to be well tolerated in older patients with newly diagnosed acute myeloid leukemia (AML) who are . For older and unfit patients with acute myeloid leukemia (AML), venetoclax plus hypomethylating agents (HMAs) have been established as a standard of care and have demonstrated improved survival compared with HMAs alone, but it is unknown how this approach compares . Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. 10-day decitabine (DEC) regimen has shown high efficacy in TP53 mut AML (Welch et al. On October 16, 2020, the Food and Drug Administration granted regular approval to venetoclax (VENCLEXTA ®, AbbVie Inc. and Genentech Inc.) in combination with azacitidine, decitabine, or low-dose . The approval of venetoclax in AML was based on two open-label nonrandomized trials. Patients had newly diagnosed AML and were ineligible for intensive chemotherapy due to comorbidities or age. In November 2018, the FDA granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly . Acute myeloid leukemia (AML) is the most common acute leukemia in the adult population, and largely affects older patients, with a median age at diagnosis of 68 years. Decitabine and venetoclax for IDH1/2-mutated acute myeloid leukemia To the Editor: Isocitrate dehydrogenase (IDH) 1/2 mutations occur in approximately 20% of older patients with acute myeloid leukemia (AML). Study M14-358 (NCT02203773) was a non-randomized, open-label clinical trial of venetoclax in combination with azacitidine (n=67) or decitabine (n=13) in newly- diagnosed patients with AML. Both venetoclax, a BCL2 inhibitor, and hypomethylating agents, such as decitabine, have shown promise in the treatment of AML and MDS, even in high-risk disease, though there is a lack of information regarding these treatments in the post-transplant setting. 2021. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia Author links open overlay panel Courtney D. DiNardo 1 Keith Pratz 2 Vinod Pullarkat 3, 4 Brian A. Jonas 5 Martha Arellano 6 Pamela S. Becker 7, 8 Olga Frankfurt 9 Marina Konopleva 1 Andrew H. Wei 10 Hagop M. Kantarjian 1 Tu Xu 11 . 1. 10-day decitabine with venetoclax for newly diagnosed intensive chemotherapy ineligible, and relapsed or refractory acute myeloid leukaemia: a single-centre, phase 2 trial. 1 The approval is valid in all . This phase II trial studies how well venetoclax and decitabine work in treating participants with acute myeloid leukemia that has come back or does not respond to treatment, or with high-risk myelodysplastic syndrome that has come back. Method: Patients with newly diagnosed AML aged >60 years or patients with secondary AML and antecedent hematological disorder were included. Study M14-358 (NCT02203773) was a non-randomized, open-label clinical trial of venetoclax in combination with azacitidine (n=67) or decitabine (n=13) in newly- diagnosed patients with AML. Decitabine Plus Venetoclax Versus Chemotherapy Among Older Patients With AML. Decitabine and venetoclax for IDH1/2-mutated acute myeloid leukemia To the Editor: Isocitrate dehydrogenase (IDH) 1/2 mutations occur in approximately 20% of older patients with acute myeloid leukemia (AML). Decitabine belongs to a class of anti-cancer drugs known as DNA methyltransferase (DNMT) inhibitors, which change how diseased cells in the blood and bone marrow grow and multiply. Venetoclax may be considered the most practice-changing drug in AML over the past few years. Adults with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in an open-label, non-randomized, multicenter phase 1b trial of venetoclax with azacitidine (AZA . FLT3 inhibitors (FLT3i) show synergism with venetoclax (VEN), and hypomethylating agents (HMA); and clinical studies have shown promising results with HMA+FLT3i, and VEN+FLT3i in FLT3 mut AML. Older patients with acute myeloid leukemia (AML) respond poorly to standard induction therapy. The patients received venetoclax plus HMAs (azacitidine or decitabine) to treat newly diagnosed or relapsed/refractory AML. DEC10-VEN consisted of daily venetoclax with decitabine 20 mg/m2 for 10 days for induction and decitabine for B-cell lymphoma 2 (BCL-2) overexpression is implicated in survival of AML cells and treatment resistance. Decitabine Plus Venetoclax Outperforms Intensive Chemotherapy Across Risk Groups. DEC10-VEN consisted of daily venetoclax with decitabine 20 mg/m 2 for 10 days for induction and decitabine for 5 days as consolidation. Background:TP53 mutation (TP53 mut) confers adverse prognosis in acute myeloid leukemia (AML) with limited response to chemotherapy. That's according to a new a study by researchers at The University of Texas . The study included 118 patients recently diagnosed with AML. A total of 35 patients (30%) had TP53 -mutated disease. Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. Giving venetoclax in combination with decitabine may help treat patients with acute myeloid leukemia. The hypomethylating agent decitabine plus venetoclax may prove to be a more effective treatment option than intensive chemotherapy for older patients with acute myeloid leukemia (AML), particularly for those who may be at an increased risk for treatment-related . Ivosidenib, an IDH1 inhibitor, is approved for the treatment of relapsed/refractory (R/R) IDH1mut AML and newly diagnosed (ND) patients . - Untreated AML patients will be treated with BP1001 plus venetoclax plus decitabine. Outcomes of R/R AML treated with 10-day decitabine and venetoclax (DEC10-VEN) were compared with IC-based regimens including idarubicin with cytarabine, with or without cladribine, clofarabine, or fludarabine, with or without additional agents. Young, fit adults with AML generally demonstrate good complete remission (CR) rates following induction therapy with the 7+3 cytarabine and anthracycline regimen. There is a deficiency of real-world data on the impact of combining venetoclax (VEN) with hypomethylating agents (HMAs) in newly diagnosed acute myeloid leukemia (AML) patients. The initial Phase 1b study with venetoclax plus HMA in untreated AML comprised of three patient cohorts, namely venetoclax plus either (i) decitabine (Group A), (ii) azacitidine (Group B), or (iii . A phase 1b study of venetoclax (ABT-199/GDC-0199) in combination with decitabine or azacitidine in treatment-naive patients with acute myelogenous leukemia who are ≥ to 65 years and not eligible . PRIMARY OBJECTIVE: I. Although all AML patients with IDH1/2 mut and/or NPM1 mut treated with frontline venetoclax combination have been reported to have excellent outcomes in terms of sustained remission and survival benefit, 3 durable remissions are possibly unique to IDH2/NPM1 co-mutated patients. in combination with azacitidine 75 mg/m 2 (IV or SC) on Days 1-7, or decitabine 20 mg/m 2 (IV) on Days 1-5 of each 28-day cycle as determined by your healthcare provider. Abstract #7009. PRIMARY OBJECTIVE: I. Online ahead of print. Future larger and randomised studies are needed to clarify activity in high-risk subsets. Based on these results, venetoclax in combination with azacitidine, decitabine, or LDAC was approved by the United States Food and Drug Administration (FDA) for use in untreated patients with AML . Decitabine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells. 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