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    Association details:
    Biomarker:RUNX1 mutation
    Cancer:Acute Myelogenous Leukemia
    Drug:Venclexta (venetoclax) (Bcl2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN

    Excerpt:
    ...- a history of mutation in TP53, RUNX1, or ASXL1...
    Trial ID:
    NCT03613532
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

    Excerpt:
    ...- AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23/KMT2 rearrangements...
    Trial ID:
    NCT05554393
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2022
    Title:

    601 Venetoclax Plus Decitabine for Young Adults with Newly Diagnosed ELN Adverse-Risk Acute Myeloid Leukemia: Updated Results of a Phase 2 Trial

    Published date:
    11/03/2022
    Excerpt:
    This multicenter, single-arm, phase 2 trial (NCT04752527) enrolled young pts (aged between 18 and 59) with ND AML...Pts with RUNX1 and FLT3-ITD mutations had higher CRc rates of 83.3% and 80%, respectively.
    Secondary therapy:
    decitabine
    DOI:
    https://doi.org/10.1182/blood-2022-166384
    Trial ID:
    NCT04752527
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2022
    Title:

    Phase 2 study of ASTX727 (cedazuridine/decitabine) plus venetoclax (ven) in patients with relapsed/refractory acute myeloid leukemia (AML) or previously untreated, elderly patients (pts) unfit for chemotherapy.

    Published date:
    05/26/2022
    Excerpt:
    ASTX727 is administered daily on days 1‐5 of each cycle and ven on days 1‐28 of the first cycle after a dose ramp up of 100-200-400 mg over 3 days...Mutations of note in the frontline cohort were RUNX1 (33%), ASXL1 (33%), DNMT3A (7%), TET2 (40%) and TP53 (20%). The overall response rate (ORR) including complete response (CR), CR with incomplete count recovery (CRi) and morphological leukemia free state (MLFS) in the FL cohort is 61% (4 CR, 4 CRi, 1 MLFS and 3 non-responders)...Total oral therapy of ASTX727+ven is safe and feasible, particularly in the advanced elderly population, and demonstrates significant efficacy in pts unfit for chemotherapy both in the FL and R/R settings.
    Secondary therapy:
    decitabine/cedazuridine
    DOI:
    10.1200/JCO.2022.40.16_suppl.7037
    Trial ID:
    NCT04746235
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2022
    Title:

    CHARACTERISTICS AND OUTCOMES OF PATIENTS WITH ACUTE MYELOID LEUKAEMIA TREATED WITH VENETOCLAX COMBINATION THERAPY: REAL-WORLD EXPERIENCE IN BOTH FRONTLINE AND RELAPSED/REFRACTORY SETTINGS

    Published date:
    05/12/2022
    Excerpt:
    A retrospective analysis was performed of all patients with AML or HR-MDS who received Ven combination therapy...The presence of NPM1 and IDH1/2 mutations were associated with high CR/CRi rates in both the frontline (85.7% and 84.6% respectively) and R/R groups (100% and 81.8%)...Notable responses were seen in patients with RUNX1 mutations in both settings (77.8% frontline, 66.6% R/R)...
    Secondary therapy:
    azacitidine
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Blood Adv
    Title:

    Venetoclax and Azacitidine Compared to Induction Chemotherapy for Newly Diagnosed Patients with Acute Myeloid Leukemia

    Published date:
    10/05/2021
    Excerpt:
    Variables that favored response to ven/aza over IC included older age, secondary AML and RUNX1 mutations...RUNX1 mutations favored ven/aza over IC...Specific variables, such as reported here for the first time RUNX1 mutations, can be identified that favor ven/aza or IC, helping to guide treatment decisions for patients who may be eligible candidates for either therapy.
    Secondary therapy:
    azacitidine
    DOI:
    https://doi.org/10.1182/bloodadvances.2021005538
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2021
    Title:

    RUNX1 MUTATIONS IN NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA DO NOT ADVERSELY IMPACT CLINICAL OUTCOMES IN THE MODERN ERA

    Published date:
    05/12/2021
    Excerpt:
    Among those with mRUNX1 VAF <30%, the addition of Ven to LIC significantly improved OS compared to LIC without Ven (median OS 25.4 m vs. 14.9 m; 2-year OS 81% vs. 12%; P=0.02)...
    Secondary therapy:
    Hypomethylating agent
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASH 2018
    Title:

    Molecular Patterns of Response and Outcome in the Chemotherapy and Venetoclax in Elderly AML Trial (CAVEAT study)

    Published date:
    11/01/2018
    Excerpt:
    Responses in response-evaluable patients were most common in NPM1 mutant AML (100%; n=7), followed by RUNX1 (90%; n=11), RAS (90%; n=10) and IDH (89%; n=9)...To date, VEN up to 600mg in combination with 5+2 induction chemotherapy is tolerable in fit elderly patients with AML. Initial response rates >80% were observed in de novo AML, as well as NPM1, RUNX1, RAS and IDH mutant AML…
    Secondary therapy:
    cytarabine + idarubicin
    DOI:
    doi.org/10.1182/blood-2018-99-114243