Venetoclax aml phase 3. Venetoclax in monotherapy In 2016, Konopleva et al.

Venetoclax aml phase 3 Jan 13, 2020 · The trial led by Dr. Fathi 2, Ghayas C. Blood. Apr 8, 2025 · SELLAS Announces Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 in r/r AML April 08, 2025 08:45 ET | Source: SELLAS Life Sciences Group, Inc. Pharmacodynamic studies have suggested superiority Nov 13, 2025 · Two phase 3 trials will study Kura Oncology’s ziftomenib for frontline acute myeloid leukemia, one with venetoclax and the other with standard induction/consolidation. Preclinical data, using various model systems including cell lines and patient samples, suggested targeting BCL-2 could be a successful therapeutic strategy in patients with acute myeloid leukemia (AML). We conducted a multicenter study phase 1b/2, Gruppo Italiano Malattie EMatologiche dell'Adulto AML1718, to investigate the safety and efficacy of venetoclax (VEN) combined with fludarabine, cytarabine, and idarubicin (V-FLAI) as an induction therapy for patients with non Jun 11, 2020 · Abstract Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Apr 25, 2023 · Article Published: 25 April 2023 Venetoclax is safe and tolerable as post-transplant maintenance therapy for AML patients at high risk for relapse Andrew Kent, Marc Schwartz, Christine McMahon Nov 2, 2023 · Venetoclax Combined with “7+3” Induction Chemotherapy Induces High Rates of MRD-Negative Remission in Newly Diagnosed AML Patients Fit for Intensive Chemotherapy Irrespective of Age Ioannis Mantzaris, Mendel Goldfinger, Nishi Shah, Jul 31, 2025 · Abstract Patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy (IC) have limited treatment options. Select a VENCLEXTA® indication. When combined with azacitidine, it leads to prolonged overall survival and rapi … Feb 8, 2024 · Long-term follow-up from the phase III VIALE-A trial demonstrated sustained overall survival (OS) benefit with venetoclax in combination with azacitidine in patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy compared to placebo plus azacitidine in all subgroups. Jun 4, 2021 · Between 2017 and 2020, 10 agents for the treatment of different subsets of acute myeloid leukemia (AML) have been approved, most with randomized trial data showing increased overall survival (OS) (Fig 1). More importantly, approval of the combination of the BCl-2 inhibitor, venetoclax, and hypomethylating agents or low dose cytarabine provided unprecedented breakthrough for the May 28, 2025 · An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts. We aimed to evaluate the efficacy and safety of low dose azacitidine plus venetoclax as maintenance therapy in acute myeloid leukaemia. Overa Nov 5, 2020 · Background:FLT3mut confers higher risk of relapse and inferior overall survival (OS) in acute myeloid leukemia (AML). The primary objective was composite complete response rate (CRc; CR+CRi); secondary endpoints were overall survival (OS), event-free survival (EFS), overall response rate (ORR), and toxicity. The BCL2 inhibitor venetoclax is highly active in acute myeloid leukaemia and synergistic with azacitidine. We hypothesised Background In a Phase 3 international clinical trial (VIALE-C), venetoclax plus low-dose cytarabine improved the response rate and overall survival versus placebo plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia who were ineligible for intensive chemotherapy. Oct 16, 2020 · - The FDA approval of VENCLEXTA for newly-diagnosed AML patients who are ineligible for intensive chemotherapy is supported by data from a series of trials including two Phase 3 trials - VIALE-A (M15-656) and VIALE-C (M16-043) Nov 7, 2025 · Official Title A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Study of Bleximenib, Venetoclax and Azacitidine for the Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia Harboring KMT2A Rearrangements or NPM1 Mutations Who Are Ineligible for Intensive Chemotherapy Efficacy and safety data of VENCLEXTA (venetoclax tablets) + azacitidine (VEN+AZA) were evaluated in a pivotal phase 3 trial 1,3 VIALE-A was a randomized (2:1), double-blind, placebo-controlled, multicenter, phase 3 clinical trial that evaluated the efficacy and safety of VEN+AZA vs placebo (PBO)+AZA in newly diagnosed patients with AML who were ≥75 years of age, or had comorbidities that May 29, 2025 · Venetoclax with azacitidine or decitabine in patients with newly diagnosed acute myeloid leukemia: Long term follow-up from a phase 1b study May 31, 2023 · Phase 1 study of ziftomenib (KO-539) in combination with venetoclax or venetoclax/azacitidine or standard induction cytarabine/daunorubicin (7+3) chemotherapy for the treatment of patients with acute myeloid leukemia. VIALE-T is a Phase 3, randomized, open-label trial in progress (NCT04161885) evaluating the safety and efficacy of venetoclax in combination with azacitidine versus best supportive care (BSC) as maintenance therapy following alloSCT in patients with AML. This open label phase II trial enrolled patients (pt … Oct 20, 2020 · Abstract Purpose: The B-cell lymphoma 2 (BCL-2) inhibitor venetoclax has an emerging role in acute myeloid leukemia (AML), with promising response rates in combination with hypomethylating agents or low-dose cytarabine in older patients. first explored the safety and efficacy of venetoclax monotherapy in relapsed refractory (R/R) AML. The decision was based on updated results from the phase III VIALE-A and VIALE-C trials. An international phase Ib/II study evaluated the safety and preliminary efficacy of venetoclax, a selective B-cell leukemia/lymphoma-2 inhibitor, together with low-dose cytarabine (LDAC) in older adults Details Phase: Prospective randomized Phase III study Monitoring Type: Study Specific Objectives: Primary study objective To assess if treatment with revumenib, in combination with azacitidine and venetoclax, prolongs overall survival (OS) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy. Revumenib is an oral menin inhibitor with clinical activity in AML patients with nucleophosmin-1 mutation (NPM1m) or lysine methyltransferase 2A rearrangements (KMT2Ar). Patients with prior MDS who have not received prior HMAs or venetoclax or chemotherapeutic agents for MDS may be enrolled in the study. Nov 5, 2021 · The phase 3 VIALE-A trial (NCT02993523) reported that venetoclax-azacitidine significantly prolonged overall survival compared with placebo-azacitidine in patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy. We conducted this meta-analysis to evaluate the clinical benefit of VEN-HMAs versus IC in various subtypes of ND-AML. 3 The study enrolled 82 adult patients aged 60 years or older and considered ineligible for intensive induction with cytarabine and anthracycline. 25 Given the effectiveness of venetoclax combinations in AML, venetoclax in combination with azacitidine was investigated in HR-MDS, first in the phase 1b M15-522 May 20, 2019 · Purpose: Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Based on phase III trials, VEN combined with either azacitidine (AZA) or low-dose cytarabine May 25, 2020 · A phase III study of venetoclax plus low-dose cytarabine in previously untreated older patients with acute myeloid leukemia (VIALE-C): A six-month update. One mechanism of chemotherapeutic resistance in AML is the overexpression of the protein B-cell lymphoma 2 (BCL-2), an anti-apoptotic protein which sequesters intracellular activators of apoptosis. Feb 25, 2025 · Venetoclax-based salvage therapy followed by Venetoclax and DLI maintenance vs. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. After the enrollment period of VIALE-C ended, we conducted an expanded access study to provide Feb 1, 2021 · This phase 2 trial (NCT03404193) enrolled ND patients with AML > 60 years and R/R patients >18 years. Apr 21, 2025 · Venetoclax plus azacitidine (VEN + AZA) is widely used in acute myeloid leukemia (AML). The most broadly practice-changing agent, in our opinion, is the BCL2 inhibitor venetoclax (VEN). Based on results from the randomized, placebo‐controlled phase 3 VIALE‐A (NCT02993523) and VIALE‐C (NCT03069352) trials, 1 , 2 , 3 , 4 venetoclax in combination with hypomethylating agents or low‐dose cytarabine (LDAC) has become standard of care in patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for Jun 12, 2024 · Here, we review the emerging mechanisms of intrinsic and acquired venetoclax resistance in AML and highlight recent efforts to identify novel strategies to overcome resistance to venetoclax. Venetoclax is a highly selective, potent, oral BCL-2 inhibitor that induces apoptosis in AML cells. See full safety and Prescribing Information for more details. However, prospective studies comparing VEN+HMA to standard intensive chemotherapy in young and fit AML patients are lacking. Patients with favorable-risk Jun 15, 2022 · This is a phase II study investigating the combination of venetoclax and CLAD/LDAC alternating with venetoclax and 5-AZA in older (≥ 60 years) or unfit patients with newly diagnosed AML. P550: A PHASE 3, RANDOMIZED TRIAL OF MAGROLIMAB IN COMBINATION WITH VENETOCLAX AND AZACITIDINE IN PREVIOUSLY UNTREATED PATIENTS WITH ACUTE MYELOID LEUKEMIA INELIGIBLE FOR INTENSIVE Thought you might appreciate this item (s) I saw in HemaSphere. Issa3, Harry Erba4, Julie Mackey Ahsan5, Daniel Corum5, Blake Tomkinson5, Tom Kozlek5, Mollie Leoni5, Eunice S. Herein, we present results from the ENHANCE-3 final analysis. One phase II trial at the MD Anderson Cancer Center combined venetoclax with CLIA (cladribine, high-dose Abstract Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Zeidan1, Amir T. Nov 15, 2022 · Study Design and Methods This is an open-label randomized phase 3 trial of fludarabine, high dose cytarabine (FLA)+gemtuzumab ozogamicin (GO) with or without venetoclax in children with relapsed AML. 10 Azacitidine at 75 mg/m 2 and venetoclax at 400 mg were given in combination daily from days 1 to 7 in patients with a new diagnosis of AML. 1 Ven/aza is a well-tolerated regimen with high response rates and the potential for deep and durable remissions, 2-5 prompting questions related to Based on results from the randomized, placebo‐controlled phase 3 VIALE‐A (NCT02993523) and VIALE‐C (NCT03069352) trials, 1 , 2 , 3 , 4 venetoclax in combination with hypomethylating agents or low‐dose cytarabine (LDAC) has become standard of care in patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for Jan 25, 2022 · Preclinically, enasidenib and azacitidine (ENA + AZA) synergistically enhance cell differentiation, and venetoclax (VEN), a small molecule Bcl2 inhibitor (i) is particularly effective in IDH2 mutated acute myeloid leukemia (IDH2^mutAML). Oct 20, 2020 · Abstract Purpose: The B-cell lymphoma 2 (BCL-2) inhibitor venetoclax has an emerging role in acute myeloid leukemia (AML), with promising response rates in combination with hypomethylating agents or low-dose cytarabine in older patients. Patients with MR Acute myeloid leukemia (AML) harboring FLT3 mutations commonly develops resistance to the combination of azacitidine and venetoclax. This review focuses on ongoing Preclinical data, using various model systems including cell lines and patient samples, suggested targeting BCL-2 could be a successful therapeutic strategy in patients with acute myeloid leukemia (AML). The primary objective was composite complete response (CR) rate (CR plus CR with incomplete blood count recovery); secondary end points were overall survival, disease-free survival (DFS), overall response Feb 3, 2025 · Venetoclax was given for 21 days with each cycle of mini–hyper-CVD (mini-HCVD; cyclophosphamide, vincristine, dexamethasone alternating with methotrexate and cytarabine). Nov 5, 2020 · A phase I trial of escalating dose of venetoclax in combination with standard 7 + 3 induction (7-day cytarabine and 3-day anthracycline) has shown that 200 mg daily for 4 days can be safely given in patients with ND AML 18–60 years of age (44). Azacitidine added to venetoclax had promising efficacy in a previous Abstract Venetoclax, a highly selective BCL-2 inhibitor, combined with hypomethylating agents (HMAs) azacitidine or decitabine, is approved for the treatment of newly diagnosed acute myeloid leukemia (ND AML) in patients who are ineligible to receive intensive chemotherapy. Jul 31, 2025 · Abstract Patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy (IC) have limited treatment options. And then subsequently in consolidation for responding patients, venetoclax in combination with intermediate-dose cytarabine, sort of following this most widely used Aug 20, 2020 · In 2018, data from a single-arm phase Ib study resulted in the FDA accelerated approval of venetoclax, an inhibitor of the antiapoptotic protein BCL-2, in combination with a hypomethylating agent Apr 26, 2025 · The combined therapy strategy of venetoclax with hypomethylating agents (HMAs) has demonstrated encouraging efficacy in the treatment of acute myeloid leukemia (AML), particularly in elderly patients or those deemed unfit for standard treatments. Wang6 Aug 19, 2024 · The phase 3 VIALE-A trial (NCT02993523) was designed to assess the effectiveness and safety of the azacitidine-venetoclax combination. Jun 12, 2025 · New results for Johnson & Johnson ’s bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia Bleximenib, an investigational selective menin inhibitor, shows potential as combination therapy for the treatment of relapsed or refractory AML and newly diagnosed, intensive chemo-ineligible AML Phase 1b data show low rate of Apr 20, 2022 · In this phase 3 trial, we randomly assigned patients with newly diagnosed IDH1 -mutated acute myeloid leukemia who were ineligible for intensive induction chemotherapy to receive oral ivosidenib Mar 18, 2023 · 2. With the increased uptake of VEN-based therapies for patients with AML, a pertinent question is whether treatment can be safely ceased among patients who have achieved sustained Nov 15, 2022 · The combination of Venetoclax (Ven) with chemotherapy can have a synergistic effect; by reducing the apoptotic threshold, Ven can facilitate increased apoptosis induced by genotoxic agents, while at the same time chemotherapy can downregulate MCL-1 that drives Ven resistance. Recently, the addition of venetoclax (V) to the chemotherapy combination of cladribine, cytarabine, and idarubicin (“CLIA”) demonstrated ENHANCE-3: A Phase 3, Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Schematic1,2 Dosing schedule (each cycle is 28 days) Oct 16, 2020 · Venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) has been approved for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are age 75 years or older, or who are ineligible for intensive induction chemotherapy. In this phase 2 trial, the investigators tested 800 mg/day oral venetoclax in 32 patients, obtaining an objective response rate of 19%, with 6% achieving a complete response (CR) and 13% achieving a CR with incomplete blood count recovery Nov 5, 2024 · Introduction Venetoclax plus hypomethylating agents (VEN+HMA) has shown remarkable efficacy in elderly and unfit AML patients. Patients needed to have ECOG performance status ≤3. Venetoclax with hypomethylating agents is a new standard of care for newly diagnosed (ND) patients with acute myeloid leukemia (AML) who are 75 years or older, or unfit for intensive chemotherapy. Prevention of relapse is a major therapeutic challenge and an unmet need for patients with acute myeloid leukemia (AML). 3 CAVEAT was designed with the aim of minimizing the risk of marrow and gastrointestinal toxicity in this elderly population by truncating the induction chemotherapy backbone of “7+3” to 5 days of Mar 7, 2025 · The registration-enabling phase III KOMET-017 trial of ziftomenib in both fit and unfit patients with KMT2A r and NPM1 m AML is expected to be initiated in 2025. However, venetoclax’s effect is still Jan 5, 2025 · A new Phase 1b clinical trial is showing encouraging results for patients with newly diagnosed acute myeloid leukemia (AML). May 30, 2025 · Key PointsDose level 3 was identified as the maximum tolerated dose in this phase 1 study of venetoclax and CLAG-M for patients with adverse-risk AML. Hypomethylating agents with venetoclax (HMA-VEN) have significantly improved outcomes and have become the standard therapy for older/unfit patients with newly diagnosed AML and are comparable to intensive chemotherapy in salvage setting. In the VIALE-A trial, overall Feb 29, 2024 · Venetoclax has been approved recently for treatment of Acute myeloid leukemia (AML). Jun 11, 2020 · Abstract Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. Here we report interim results from phase 1a in patients with R/R AML. Oct 27, 2022 · In a phase 2 study, sorafenib + AZA in patients with relapsed FLT3 -ITD–mutant AML resulted in a response rate of 46% (27% with complete response with incomplete count recovery, 16% with complete response, and 3% with partial response). In this trial, however, patients who received Jul 3, 2025 · A randomized phase 2 trial of 28-day (Arm A) versus 14-day (Arm B) schedule of venetoclax + azacitidine in newly diagnosed acute myeloid leukemia patients ≥ 60 years. Whether or not VEN-HMAs are of clinical benefit remains uncertain. Gilteritinib combines synergistically with the BCL-2 inhibitor venetoclax in preclinical models of FLT3mut AML. Apr 10, 2023 · Objectives: The meta-analysis sought to evaluate the efficacy and safety of a combination of venetoclax (Ven) and azacitidine (AZA) in the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Jun 12, 2025 · All-oral decitabine-cedazuridine (DEC-C) + venetoclax (VEN) in patients with newly diagnosed acute myeloid leukemia (AML) ineligible for induction chemotherapy: phase 1/2 clinical trial results. In a phase 1b study, we assessed the safety and efficacy of Ven with daunorubicin and cytarabine in patients with newly diagnosed AML. Dec 9, 2022 · Venetoclax is an oral, potent, selective inhibitor of B-cell lymphoma 2, which is an antiapoptotic protein highly expressed in AML stem cells that rely on this protein for survival. VENCLEXTA is an oral therapy for select AML, CLL and SLL patients. Ven in combination with hypomethylating agents has shown to not only eradicate AML blasts but also target and eliminate Nov 15, 2022 · Methods This is a phase 2 clinical trial (NCT02115295) investigating venetoclax combined with CLIA for patients aged ≤65 years of age with newly diagnosed AML or high-risk MDS. The Chemotherapy and Venetoclax in Elderly AML Trial (CAVEAT) was first to combine venetoclax with intensive chemotherapy in newly diagnosed patients aged ≥65 years. Long-term follow-up of the phase 3 VIALE-A clinical trial of venetoclax plus azacitidine for patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy. Feb 3, 2025 · Venetoclax was given for 21 days with each cycle of mini–hyper-CVD (mini-HCVD; cyclophosphamide, vincristine, dexamethasone alternating with methotrexate and cytarabine). Jul 18, 2022 · The FMS-related tyrosine kinase 3 (FLT3) inhibitor gilteritinib is standard therapy for relapsed/refractory FLT3 -mutated (FLT3mut) acute myeloid leukemia (AML) but seldom reduces FLT3mut burden or induces sustained efficacy. 3 CAVEAT was designed with the aim of minimizing the risk of marrow and gastrointestinal toxicity in this elderly population by truncating the induction chemotherapy backbone of “7+3” to 5 days of Jun 11, 2020 · Abstract Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. This is an open-label phase 3 randomized multicenter international trial in children with relapsed acute myeloid leukemia (AML), to assess if venetoclax combined with FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall survival compared to FLA+GO. Sep 4, 2020 · 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. Venetoclax is a selective, potent, orally bioavailable, small molecule inhibitor of B-cell lymphoma (BCL)-2 that restores programmed Mar 20, 2019 · Effective treatment options are limited for patients with acute myeloid leukemia (AML) who cannot tolerate intensive chemotherapy. In vitro studies have found a synergistic effect of hypomethylating agents (HMA) with venetoclax (VEN) on AML cells and since the phase 3 VIALE-A trial demonstrated a survival benefit, HMA + VEN has become the standard of care in the frontline setting for older/unfit adults with AML Mar 20, 2025 · P510: the impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia Apr 10, 2025 · CAVEAT was an investigator-sponsored phase 1b study enrolling patients aged ≥65 years with newly diagnosed AML considered suitable for IC. Your message has been successfully sent to your colleague. Jul 31, 2025 · ENHANCE-3, a randomized phase 3 study, was designed to determine whether magrolimab plus venetoclax and azacitidine was superior to placebo plus venetoclax and azacitidine in patients with previously untreated AML ineligible for IC. Apr 17, 2025 · Hypomethylating agent (HMA) plus venetoclax (VEN) regimens are standard of care in patients with acute myeloid leukemia (AML) ineligible for intensive chemotherapy. Dec 9, 2024 · So it was an early phase, Phase Ib study of venetoclax in combination with 7+3. Miller, Christian Récher, Courtney D. In this phase 2 trial, the investigators tested 800 mg/day oral venetoclax in 32 patients, obtaining an objective response rate of 19%, with 6% achieving a complete response (CR) and 13% achieving a CR with incomplete blood count recovery Aug 12, 2020 · - Data from Phase 3 VIALE-A study showed venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine plus placebo in newly-diagnosed patients with AML who are ineligible for chemotherapy Aug 26, 2025 · Relapse of AML is driven by chemotherapy resistant stem cells. This pooled analysis of the phase 3 VIALE-A trial (NCT02993523) and phase 1b study (NCT02203773) examined prognostic stratification Aug 12, 2020 · New England Journal of Medicine Publishes Positive Phase 3 Data of Venetoclax Combination in Acute Myeloid Leukemia (AML) Patients - Data from Phase 3 VIALE-A study showed venetoclax plus Nov 17, 2025 · Olutasidenib continued to demonstrate durable efficacy and a manageable safety profile in a broad range of patients with R/R mIDH1 AML, including those previously treated with venetoclax-based regimens Rigel advances its strategic collaborations to further evaluate olutasidenib with the activation of a fifth study with MD Anderson and enrollment of the first patient in the CONNECT TarGeT-D Apr 4, 2025 · A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy PB1885: PHASE 1 STUDY OF ZIFTOMENIB IN COMBINATION WITH VENETOCLAX, VENETOCLAX/AZACITIDINE, OR STANDARD INDUCTION (7 + 3) CHEMOTHERAPY IN PATIENTS WITH ACUTE MYELOID LEUKEMIA Apr 4, 2025 · A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy PB1885: PHASE 1 STUDY OF ZIFTOMENIB IN COMBINATION WITH VENETOCLAX, VENETOCLAX/AZACITIDINE, OR STANDARD INDUCTION (7 + 3) CHEMOTHERAPY IN PATIENTS WITH ACUTE MYELOID LEUKEMIA Venetoclax has proven to be a promising therapy for newly diagnosed, relapsed and refractory AML patients ineligible for induction chemotherapy. Nov 5, 2024 · KOMET-007, an ongoing, open-label, dose escalation (phase 1a) and expansion (phase 1b) study, aims to evaluate ziftomenib in combination with standard chemotherapies in adults with newly diagnosed and R/R NPM1- m or KMT2A- r AML (NCT05735184). In this final analysis, 85 patients (median age, 71 years) were followed up for a median of 41. Venetoclax (ven) plus azacitidine (aza) is superior to aza alone for patients with newly diagnosed acute myeloid leukemia (AML) who are unsuitable candidates for intensive chemotherapy (IC). This study explored the role of static and dynamic profiles of mutational clonal burden to predict outcomes Nov 18, 2024 · The AML treatment landscape has significantly changed in recent years with the approval of targeted therapies in the front-line and relapsed/refractory settings, including inhibitors of FLT3 and IDH1/2 mutations. Nov 21, 2024 · The European LeukemiaNet (ELN) acute myeloid leukemia (AML) genetic risk classification systems are based on response to intensive chemotherapy; their ability to discriminate outcomes in older patients treated with venetoclax-azacitidine may be suboptimal. The trial, led by Dr. 8 months Abstract Venetoclax (Ven), when combined with intensive chemotherapy, shows promise for untreated acute myeloid leukemia (AML), but its integration with the 7+3 regimen remains underexplored. KEY POINTS Based on the benefit with azacitidine plus venetoclax in acute myeloid leukemia, this combination is being evaluated in patients with higher-risk myelodysplastic syndromes. PHASE 1 STUDY OF ZIFTOMENIB IN COMBINATION WITH VENETOCLAX, VENETOCLAX/AZACITIDINE, OR STANDARD INDUCTION (7+3) CHEMOTHERAPY IN PATIENTS WITH ACUTE MYELOID LEUKEMIA Amer M. While no published data exist on the use of the standard IC regimen (7 + 3) with venetoclax, several clinical trials are underway or about to begin (NCT03709758 and NCT04628026). Andrew Wei and colleagues was a phase Ib/II study that assessed the safety and efficacy of an induction regimen of venetoclax and low-dose cytarabine in newly diagnosed AML patients. 3% for VEN plus decitabine in newly diagnosed young AML patients with adverse risk [7]. It was a dose escalation in terms of venetoclax cumulative dose, so duration essentially of venetoclax at eight, 11, 14 days in combination with 7+3. Apr 3, 2025 · The impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia. As predicted by this work, the use of venetoclax in the clinical setting has resulted in promising outcomes for patients with this disease. This review focuses on ongoing Jun 12, 2025 · Azacitidine and venetoclax is a standard frontline treatment regimen for newly diagnosed older adults with AML; however, long-term outcomes remain poor. Ziftomenib in combination with venetoclax and azacitidine: Results from the KOMET-007 2 Apr 8, 2025 · SELLAS Announces Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 in r/r AML April 08, 2025 08:45 ET | Source: SELLAS Life Sciences Group, Inc. Venetoclax is a highly selective, potent, oral BCL-2 inhibitor that induces In recent studies, the combination of venetoclax with intensive chemotherapy has demonstrated encouraging results in the treatment of fit patients with de novo and relapsed/refractory acute myeloid leukemia (AML). An international phase Ib/II study evaluated the safety and preliminary efficacy of venetoclax, a selective B-cell leukemia/lymphoma-2 inhibitor, together with low-dose cytarabine (LDAC) in older adults with AML. May 28, 2021 · To confirm these benefits, the VERONA study, a randomized, double-blind, phase 3 study (NCT04401748) of patients with treatment-naïve HR-MDS, will assess the safety and efficacy of Ven combined with Aza including CR rate and overall survival. Current ongoing clinical trials are evaluating its effectivity as frontline therapy for all acute Aug 23, 2024 · Venetoclax (VEN) plus hypomethylating agents (HMAs) is recommended for newly diagnosed (ND) elderly AML patients or those who were ineligible for intensive chemotherapy [2]. Jul 20, 2020 · The B-cell lymphoma 2 (BCL-2) inhibitor venetoclax has an emerging role in acute myeloid leukemia (AML), with promising response rates in combination with hypomethylating agents or low-dose cytarabine in older patients. Nov 5, 2024 · Background: Induction chemotherapy in acute myeloid leukemia (AML) has historically combined an anthracycline with standard-dose cytarabine (“7+3”) in fit patients and is considered the standard of care despite complete remission (CR) rates of 50-70%. Pratz KW, Jonas BA, Pullarkat V, et al. aAzacitidine administered per region-specific labeling. Methods We searched PubMed, Embase, Cochrane Sep 2, 2022 · In this phase 1–2 study (phase 1 portion presented in this Article), we studied the addition of the BCL-2 inhibitor venetoclax to standard-of-care azacitidine in patients with high-risk myelodysplastic syndromes. Long-term results of a phase Ib trial in 107 patients demonstrated that more than 80% of patients had complete remission plus marrow complete remission. gov identifier: NCT04140487). FLAG-Ida for relapsed or refractory acute myeloid leukemia after allogeneic stem cell transplantation Venetoclax is being evaluated as a treatment for younger patients with AML and various IC regimens [46]. However, due to differences in the research focuses of various research centers, the results have not yet comprehensively and systematically Oct 11, 2023 · Blood Cancer Journal - Efficacy of venetoclax combined with hypomethylating agents in young, and unfit patients with newly diagnosed core binding factor acute myeloid leukemia Nov 27, 2023 · A phase 2 trial in our institute demonstrated a CRc rate of 78. Pharmacodynamic studies have suggested superiority Mar 18, 2023 · 2. The most common grade 3–4 adverse events were thrombocytopenia (33 [85%] of 39), neutropenia (29 [74%]), and febrile neutropenia (eight [21%]). Key secondary study objectives: To assess if treatment with The prognosis of adult acute myeloid leukemia (AML) remains poor, with the long-term survival rate less than 50%. A full list of eligibility criteria are published. However, the current paradigms of treatment are changing through a better understanding of the disease genetics and pathophysiology. May 20, 2025 · The standard induction treatment for acute myeloid leukemia (AML) has limited efficacy for patients with non–low-risk AML. This resistance can be overcome with the addition of gilteritinib, an oral FLT3 inhibitor, resulting in high complete response (CR) rates with acceptable toxicity, according to a study published in the Journal of Clinical Oncology. Wang6 May 1, 2024 · Methods: This phase I/II study evaluated azacitidine, venetoclax, and gilteritinib in two cohorts: patients with (1) newly diagnosed FLT3 -mutated AML who were unfit for intensive chemotherapy or (2) relapsed/refractory FLT3 -mutated AML (ClinicalTrials. 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 FLT3mut AML. Jul 5, 2022 · The clinical benefit of adding venetoclax (VEN) to hypomethylating agents or low-dose cytarabine in older and/or unfit patients with newly diagnosed acute myeloid leukemia (AML) has been confirmed in phase 3 studies. 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. 2024;144:2907. Mar 8, 2024 · Long-term survival improved with the use of venetoclax (Venclexta) plus azacitidine (Vidaza) for patients with newly diagnosed acute myeloid leukemia (AML), according to results from the phase 3 VIALE-A trial (NCT02993523) published in the American Journal of Hematology. Abstract Venetoclax has transformed the therapeutic landscape of acute myeloid leukemia (AML). Abstract Venetoclax, a highly selective BCL-2 inhibitor, combined with hypomethylating agents (HMAs) azacitidine or decitabine, is approved for the treatment of newly diagnosed acute myeloid leukemia (ND AML) in patients who are ineligible to receive intensive chemotherapy. May 19, 2025 · Background Venetoclax with hypomethylating agents (VEN-HMAs) has shown inconsistent efficacy versus induction chemotherapy (IC) in newly diagnosed AML (ND-AML). Oct 8, 2025 · Official Title Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia Keywords. Venetoclax in monotherapy In 2016, Konopleva et al. The tolerability and efficacy of venetoclax in combination with intensive chemotherapy in AML is unknown. The primary end points were the maximum tolerated dose of gilteritinib (phase I) and the combined complete Aug 19, 2024 · The phase 3 VIALE-A trial (NCT02993523) was designed to assess the effectiveness and safety of the azacitidine-venetoclax combination. In vitro studies have found a synergistic effect of hypomethylating agents (HMA) with venetoclax (VEN) on AML cells and since the phase 3 VIALE-A trial demonstrated a survival benefit, HMA + VEN has become the standard of care in the frontline setting for older/unfit adults with AML Aug 6, 2025 · Adding magrolimab to venetoclax and azacitidine did not improve overall survival or complete remission rates in patients with previously untreated acute myeloid leukemia (AML) who were ineligible Mar 20, 2025 · P510: the impact of post-remission granulocyte colony-stimulating factor use in the phase 3 studies of venetoclax combination treatments in patients with newly diagnosed acute myeloid leukemia Apr 10, 2025 · CAVEAT was an investigator-sponsored phase 1b study enrolling patients aged ≥65 years with newly diagnosed AML considered suitable for IC. Nov 1, 2024 · Older/unfit adults with AML have worse outcomes and fewer treatment options than their younger/fit counterparts. Ioannis Mantzaris at a tertiary academic center, evaluated the safety and effectiveness of adding venetoclax (Venclexta, Abbvie) to the standard “7+3” chemotherapy regimen, which includes Feb 2, 2024 · The maximum tolerated dose was not reached, and the recommended phase 2 dose was established as oral decitabine 35 mg plus cedazuridine 100 mg for 5 days and venetoclax (400 mg) for 14 days. Dec 6, 2024 · The impact of post-remission G-CSF use in the phase 3 studies of venetoclax in AML / Árpád Illés, cancer, Catherine L. While the current standard of Abstract Venetoclax plus azacitidine represents a key advance for older, unfit patients with acute myeloid leukemia (AML). 33 Recent data from a phase 3 trial of venetoclax and AZA in older, unfit patients with ND AML reported no Mar 8, 2024 · Long-term survival improved with the use of venetoclax (Venclexta) plus azacitidine (Vidaza) for patients with newly diagnosed acute myeloid leukemia (AML), according to results from the phase 3 VIALE-A trial (NCT02993523) published in the American Journal of Hematology. Venetoclax is a BH3-mimetic and induces apoptosis via Bcl-2 inhibition. There were no dose-limiting toxicities at dose level 1 (DL1; n = 3, 400 mg/d) or DL2 (n = 6, 600 mg/d); DL2 was the recommended phase 2 dose and explored further (n = 10). We conducted a phase 2 study to compare the efficacy and safety of VEN+HMA versus the standard 7+3 regimen in newly diagnosed AML patients Aug 12, 2020 · - Data from Phase 3 VIALE-A study showed venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine plus placebo in newly-diagnosed patients with AML who are ineligible for chemotherapy Aug 26, 2025 · Relapse of AML is driven by chemotherapy resistant stem cells. The phase 3 ENHANCE-3 study aimed to determine whether magrolimab (magrolimab arm) was superior to placebo (control arm) when either was combined with venetoclax and azacitidine. Jul 19, 2022 · Prevention of relapse is a major therapeutic challenge and an unmet need for patients with acute myeloid leukemia (AML). Aug 12, 2020 · Older patients with acute myeloid leukemia (AML) have a dismal prognosis, even after treatment with a hypomethylating agent. The phase 3 QUAZAR AML-001 study showed an overall survival benefit with oral azacitidine maintenance. gigx zzuc uhino xxsrov dkqmr gpxavlza oqsxq ebs qqngtr vqdyu zleupzl hlvajhw uabhzl zny nzy