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Association details:
Evidence:
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
10/14/2020
Excerpt:
Acute Myeloid Leukemia (Age ≥18 years): IDH1 of IDH2 mutation or FLT3 mutation…Venetoclax-based therapy with decitabine noted as preferred...
Secondary therapy:
decitabine
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
10/14/2020
Excerpt:
Acute Myeloid Leukemia (Age ≥18 years): IDH1 of IDH2 mutation or FLT3 mutation…Venetoclax-based therapy with azacitidine noted as category 1 and preferred...
Secondary therapy:
azacitidine
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

219 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

Published date:
11/03/2022
Excerpt:
431 patients with confirmed AML who were previously untreated and ineligible for intensive therapy were randomly assigned 2:1 to Aza plus either Ven (286 patients) or Pbo (145 patients)....For patients in the IDH1/2 mutant subgroup, median OS was reached at final analysis, at 19.9 mo (95% CI, 12.2-27.7) in the Ven+Aza group and 6.2 mo (95% CI, 2.3-12.7) in the Pbo+Aza group (HR, 0.314; 95% CI, 0.189 to 0.522; P<0.001)...
Secondary therapy:
azacitidine
DOI:
https://doi.org/10.1182/blood-2022-158518
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Impact of Venetoclax and Azacitidine in Treatment-Naive Patients with Acute Myeloid Leukemia and IDH1/2 mutations

Published date:
01/19/2022
Excerpt:
Composite complete remission (CRc, complete remission [CR]+CR with incomplete hematologic recovery [CRi]) rates (venetoclax+azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months. Patients with IDH1/2mut who receive venetoclax+azacitidine had high response rates, durable remissions and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut.
Secondary therapy:
azacitidine
DOI:
10.1158/1078-0432.CCR-21-3467
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with IDH 1/2 Mutations

Published date:
11/05/2020
Excerpt:
Ven+Aza compared to Aza monotherapy resulted in higher response rates, longer DoR, and mOS among treatment-naïve pts with IDH1/2mut ineligible for intensive chemotherapy.
Secondary therapy:
azacitidine
DOI:
10.1182/blood-2020-134736
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

461 Results of Venetoclax and Azacitidine Combination in Chemotherapy Ineligible Untreated Patients with Acute Myeloid Leukemia with IDH 1/2 Mutations

Published date:
11/04/2020
Excerpt:
IDH1/2 mut pts achieved higher CR+CRh rates with Ven+Aza treatment as compared to pts with IDH not detected (72%/60%)....Ven+Aza compared to Aza monotherapy resulted in higher response rates, longer DoR, and mOS among treatment-naïve pts with IDH1/2 mut ineligible for intensive chemotherapy.
Secondary therapy:
azacitidine
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VENETOCLAX WITH AZACITIDINE VS AZACITIDINE IN TREATMENT-NAÏVE PATIENTS WITH ACUTE MYELOID LEUKEMIA INELIGIBLE FOR INTENSIVE THERAPY-VIALE-A

Published date:
06/14/2020
Excerpt:
We evaluated efficacy of AZA+VEN combination regimen...CR+CRi and OS by molecular subgroups, and event-free survival (EFS). Response rates in pts with DeNovo and secondary AML were 66%/30% and 67%/23% respectively. Other secondary endpoints are summarized in the Table.
Secondary therapy:
azacitidine
Evidence Level:
Sensitive: C3 – Early Trials
Title:

[Efficacy and Survival of Venetoclax Based Regimen in the Treatment of Acute Myeloid Leukemia

Published date:
12/10/2023
Excerpt:
VEN-based regimen can achieve a high response rate, especially in unfit AML with acceptable safety, and some patients can achieve MRD negative. It is also effective in NPM1-, IDH1/2-positive patients with long survival time.
DOI:
10.19746/j.cnki.issn.1009-2137.2023.06.012
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1519 Despite High Rates of Remission, Treatment of IDH-Mutant AML with Hypomethylating Agents and Venetoclax Is Associated with Frequent Treatment Delays, Modifications, and Transfusions

Published date:
11/02/2023
Excerpt:
The CR/CRi rate was 76% (n=38; 30% CR, n=15; 46% CRi, n=23) for ND patients and 52% (n=23; 32% CR, n=14; 20% CRi, n=9) for R/R patients....In a single-center retrospective setting, HMA/Ven is efficacious in achieving CR/CRi in ND and R/R IDH-mutant AML.
Secondary therapy:
Hypomethylating agent
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1470 Genetic Mutation and Outcome of Venetoclax-Based Therapy in Newly Diagnosed AML in the Real World: Hokkaido Leukemia Net Study

Published date:
11/02/2023
Excerpt:
A total of 89 AML cases registered in HLN from May 2021 to April 2023 were initially treated by VEN-based therapy....Furthermore, the ratio of CR or CRi was more than 80% in the patients with mutation of CEBPA-bZIP, DNMT3A, IDH1, IDH2, and NPM1 mutation-positive groups, respectively.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

1488 First-Line Venetoclax and a Hypomethylating Agent or Conventional Chemotherapy in Older Adults with IDH-Mutated AML

Published date:
11/02/2023
Excerpt:
These findings provide evidence suggestive of the comparable efficacy of VEN+HMA and IC in older adults with IDHmut AML. Both treatment strategies appear to offer significantly prolonged survival relative to HMA monotherapy.
Secondary therapy:
Hypomethylating agent
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Venetoclax in Combination With Low‑Dose Cytarabine and/or Actinomycin D in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) Patients With IDH1 or IDH2 Mutations

Published date:
09/01/2023
Excerpt:
The median RFS was 9.2 months (95% CI: 0–20.8), median OS 16 months (95% CI:7.9–19.5), 12- and 24-month OS was 55% and 39%, respectively. The ORR (CR+CRi+MLFS) was 81%. CR, CRi, and MLFS rates were 63%, 11% and 7%, respectively….ACTIVE regimen demonstrated high antileukemic efficacy in R/R IDHm AML.
Secondary therapy:
cytarabine + dactinomycin
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Real‑World Outcomes of Decitabine + Venetoclax With IDH Inhibition for AML

Published date:
09/01/2023
Excerpt:
Assess outcomes in IDH1/2mut AML treated with “triplet regimen” of 10-day decitabine, venetoclax, and IDHi (DAC+VEN+IDHi)….One patient had PR after cycle 1. Best responses to DAC+VEN+IDHi were unchanged after cycle 1. Five patients were alive at last follow-up (median of 409 days from cycle 1, day 1 of DAC+VEN+IDHi); 4 were in CR and 1 in PR.
Secondary therapy:
IDH2 inhibitor + decitabine
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

REATMENT PATTERNS AND REAL-WORLD OUTCOMES OF MOLECULAR SUBGROUPS IN PATIENTS WITH ACUTE MYELOID LEUKEMIA RECEIVING FRONTLINE VENETOCLAX-BASED THERAPY

Published date:
05/11/2023
Excerpt:
Adult patients (age ≥ 18 years) who received first-line (1L) VEN-based tx for AML and had available dosing information were included....Median OS for the population was 13.9 months (95% CI: 11.8, 16.6), and differed by mutation status (13.1 months for IDH1 positive patients, 42.0 months for IDH2 positive patients, not reached for FLT3-ITD positive patients, and 42.0 months for NPM1 positive patients).
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

CL-2/BCL-XL INHIBITION INDUCES APOPTOSIS AND CIRCUMVENTS VENETOCLAX RESISTANCE IN TP53-MUTATED ACUTE MYELOID LEUKEMIA

Published date:
05/11/2023
Excerpt:
...TP53 mutation (p=0.005) and complex karyotype (p=0.003) were the strongest predictors of venetoclax resistance, while IDH2 (p=0.006) and SRSF2 (p=0.007) mutations predicted favorable responses (FigureA).
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

711 High Response and Prolonged Treatment-Free Remission after a Short-Course of Modified Intensive Chemotherapy and Venetoclax in Elderly AML: An Updated Analysis of the Caveat Trial

Published date:
11/03/2022
Excerpt:
The CAVEAT study enrolled pts aged ≥65 years with de novo or secondary/therapy-related AML (sAML) considered suitable for intensive chemotherapy....By intention-to-treat, the overall response (CR/CRi) rate was 73%. CR/CRi was 90% in de novo AML (vs 51% in sAML), 84% in intermediate karyotype (vs 69% in adverse), 76% and 83% in NPM1 and IDH2 mutant AML, respectively.
Secondary therapy:
; cytarabine + idarubicin hydrochloride
DOI:
https://doi.org/10.1182/blood-2022-165021
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Comparison of Patients with Newly Diagnosed (ND) Acute Myeloid Leukemia (AML) Treated with Venetoclax and Hypomethylating Agents Vs Other Therapies By TP53 and IDH1/2 Mutation: Results from the AML Real World Evidence (ARC) Initiative

Published date:
11/03/2022
Excerpt:
In the unfit subgroup, VEN pts received VEN-AZA (77.6%) or VEN-DEC (22.4%) and 55.2% of CON pts received high intensity regimens...Among pts with IDH1/2 mutations, CRc was significantly higher in overall VEN versus CON (87.9% vs. 54.2%; p<0.01) and in the unfit subgroup (85.7% vs. 52.9%; p<0.05)...Pts with ND AML receiving VEN-HMA had significantly higher rates of CRc than matched pts on non-VEN-based regimens in the overall population...
Secondary therapy:
decitabine; azacitidine
DOI:
https://doi.org/10.1182/blood-2022-159615
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

538 Outcomes of Acute Myeloid Leukemia Relapsed Post-Allogeneic Hematopoietic Stem Cell Transplant Treated with Hypomethylating Agents and Venetoclax Combination: A Single Center Experience

Published date:
11/03/2022
Excerpt:
In this largest retrospective cohort study to date, HMA+Ven appeared to be effective and well-tolerated in this setting, with the potential for durable remissions and MRD negativity, especially in the presence of certain molecular aberrations such as NPM1 and IDH 1/2 mutations.
Secondary therapy:
Hypomethylating agent
DOI:
https://doi.org/10.1182/blood-2022-165661
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

837 Association of Genetic Characteristics with Response to Venetoclax Plus Hypomethylating Agents in Relapsed and Refractory Acute Myeloid Leukemia

Published date:
11/03/2022
Excerpt:
In this study, we aimed to evaluate the efficacy of VEN combined with hypomethylating agents (HMA) and identify the potentially predictive factors for response in R/R AML....Mutations in IDH1/2, NPM1 and ASXL1 predicted superior response to VEN-based therapy (CRc: 78.3%, 70.8% and 65.0%, respectively), while mutations in active signaling, such as FLT3-ITD, K/NRAS predicted inferior response (CRc: 29.0% and 28.6%).
Secondary therapy:
Hypomethylating agent
DOI:
https://doi.org/10.1182/blood-2022-158762
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Genetic characteristics predict response to venetoclax plus hypomethylating agents in relapsed or refractory acute myeloid leukemia

Published date:
10/25/2022
Excerpt:
With a median follow-up of 11.2 (95%CI, 7.2-14.8) months, 1- and 2-year overall survival were 46.9% (95% CI, 37.8%-58.1%) and 38.9% (95% CI, 28.7%-52.9%), respectively…Mutations in IDH1/2, NPM1, ASXL1 and chromatin-cohesin genes predicted superior response to VEN-based therapy, whereas mutations in active signaling genes such as FLT3-ITD and K/NRAS predicted inferior response...VEN combined with HMA was effective with R/R AML patients, and the response to treatment was associated with genetic characteristics.
Secondary therapy:
Hypomethylating agent
DOI:
10.1111/joim.13581
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Re-induction with venetoclax in combination with hypomethylating agents (HMAs) versus FLAG-IDA in relapsed or refractory AML.

Published date:
05/26/2022
Excerpt:
We retrospectively analyzed 47 patients with AML...A Cox proportional hazards model was used to investigate the effects of commonly mutated genes (NPM1, ASXL1, FLT3, IDH1/2, RAS, TP53, TET2) on OS in venetoclax-based re-induction, and identified IDH1/2 mutations as having a favorable impact in the relapsed/refractory setting (HR 0.01, 95% CI 0.0001-0.7214)....Although limited by sample size, IDH1/2 mutations may convey a better prognosis in the relapsed/refractory setting when treated with venetoclax + HMAs.
Secondary therapy:
azacitidine; decitabine
DOI:
10.1200/JCO.2022.40.16_suppl.e19030
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

AZACITIDINE PLUS VENETOCLAX FOR THE TREATMENT OF RELAPSED AND FIRST-LINE AML PATIENTSAZACITIDINE PLUS VENETOCLAX FOR THE TREATMENT OF RELAPSED AND FIRST-LINE AML PATIENTS

Published date:
05/12/2022
Excerpt:
This retrospective study included consecutive patients treated with VEN-AZA for R/R AML and ND AML....ASXL1, IDH1/2 and SRSF2 mutations were associated with a trend in a higher response rate in the R/R group.
Secondary therapy:
azacitidine
Evidence Level:
Sensitive: C3 – Early Trials
Source:
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
Title:

Short-term efficacy of venetoclax combined with azacitidine in acute myeloid leukemia: a single-institution experience

Published date:
02/14/2022
Excerpt:
After one cycle of treatment, 13 patients with IDH1/2 mutations and 4 that were TP53-positive all achieved CR/CRi. The CR/CRi rate of 18 patients with NPM1 mutations was 77.8%. Five patients with RUNX1-RUNX1T1 combined with KIT D816 mutation (two initial diagnoses and three recurrences) had no remission. Ven+ AZA was tolerable for AML patients...Ven+AZA has acceptable safety in previously untreated patients unfit for standard chemotherapy, patients with R/R AML can achieve a high response rate, and some patients can achieve MRD negativity.
DOI:
10.3760/cma.j.issn.0253-2727.2022.02.008
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Impact of Venetoclax and Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia and IDH1/2 Mutations

Published date:
01/31/2022
Excerpt:
To evaluate efficacy and safety of venetoclax + azacitidine among treatment-naïve patients with IDH1/2-mutant (mut) acute myeloid leukemia (AML)....Composite complete remission [CRc, complete remission (CR)+CR with incomplete hematologic recovery (CRi)] rates (venetoclax + azacitidine/azacitidine) among patients with IDH1/2mut were 79%/11%, median duration of remission (mDoR) was 29.5/9.5 months, and median overall survival (mOS) was 24.5/6.2 months....In patients with IDH1mut, CRc rates (venetoclax + azacitidine/azacitidine) were 66.7%/9.1% and mOS 15.2/2.2 months. In patients with IDH2mut, CRc rates were 86.0%/11.1% and mOS not reached (NR)/13.0 months....Patients with IDH1/2mut who received venetoclax + azacitidine had high response rates, durable remissions, and significant OS; cytogenetic risk did not mitigate the favorable outcomes seen from this regimen for IDH1/2mut.
Secondary therapy:
azacitidine
DOI:
10.1158/1078-0432.CCR-21-3467
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Combination Treatment of Venetoclax and Hypomethylating Agents (HMA) or Low-Dose Cytarabine (LDAC) for Patients with Acute Myeloid Leukemia (AML) – Real-World Data from Two German Academic Centers

Published date:
12/24/2021
Excerpt:
As in patients treated with VEN combinations at fist line, the NPM1 and IDH1/2 genotype was associated with better response and survival.
DOI:
10.1182/blood-2021-150943
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Clinical Experience With Venetoclax in Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia.

Published date:
11/08/2021
Excerpt:
In contrast, patients with NPM1, IDH1, or IDH2 mutations without co-occurring FLT3-ITD mutations showed an increased sensitivity to VEN-based therapy: 11.2 (5 - 24.3) months versus 5.0 (0.8 - 22.1), respectively (HR 0.53, 95% CI 0.23 – 1.21, p = 0.131).
DOI:
10.21203/rs.3.rs-1026952/v1
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A Phase II Study of 5-Azacytidine (AZA) and Venetoclax As Maintenance Therapy in Patients with Acute Myeloid Leukemia (AML) in Remission

Published date:
11/04/2021
Excerpt:
ELN-favorable patients (n = 11), with a high incidence of normal diploid karyotypes (11/11), NPM1 mutations (11/11) and IDH1/2 mutations (5/11), did particularly well, with no relapses observed so far within this group...Maintenance therapy with AZA-VEN is a feasible and tolerable strategy in AML patients who have achieved CR following both high- and low-intensity induction regimens.
Secondary therapy:
azacitidine
DOI:
10.1182/blood-2021-150573
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Phase II Trial of Ten-Day Decitabine with Venetoclax (DEC10-VEN) in Acute Myeloid Leukemia: Updated Outcomes in Genomic SubgroupsClinically Relevant Abstract

Published date:
11/04/2021
Excerpt:
Pts received decitabine 20 mg/m2 on D1-10 until CR/CRi, followed by 5-day cycles. VEN dose was 400 mg daily but held on C1D21 if D21 bone marrow (BM) had ≤5% blasts….DEC10-VEN offered high rates of CR/CRi, negative MRD, favorable OS and RFS across several genomic subgroups of treatment-naïve AML including NPM1, FLT3, IDH1/2...
Secondary therapy:
decitabine
DOI:
10.1182/blood-2021-153227
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy, Toxicity and Cost of Venetoclax-Based Combinations for the Treatment of Acute Myeloid Leukemia: Real-World Evidence from a Canadian Academic Center

Published date:
11/04/2021
Excerpt:
40 patients received 41 ven-based treatments between November 2017 and July 2021…73% of patients that achieved a response to ven...The presence of NPM1 or IDH1/2 mutations was predictive of high response rates.
DOI:
10.1182/blood-2021-149967
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Safety and Efficacy: Clinical Experience of Venetoclax in Combination With Hypomethylating Agents in Both Newly Diagnosed and Relapsed/Refractory Advanced Myeloid Malignancies

Published date:
03/09/2021
Excerpt:
Of 26 newly diagnosed AML patients, the CR/CRi rate was 53.8%. The median DOR and OS were 6.9 months and not reached, respectively. Of 39 R/R AML patients, the CR/CRi rate was 38.5%. The median DOR and OS were both 8.1 months. Responders to HMA and venetoclax were enriched for TET2, IDH1, and IDH2 mutations, while nonresponders were associated with FLT3 and RAS mutations.
DOI:
10.1097/HS9.0000000000000549
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Clinical Outcomes of Acute Myeloid Leukemia Patients Bridged to Allogeneic Stem Cell Transplant By Venetoclax Combination Therapy

Published date:
11/04/2020
Excerpt:
All AML pts who received treatment with aza/ven, dec/ven or LDAC/ven as either initial induction or for RR disease...A total of 130 pts were treated with ven combo therapy with 18 pts (13.8% of all pts) receiving a subsequent alloSCT. While pts with DNMT3A, NPM1, IDH1/2 and FLT3 mutations had a high response rate to ven therapy...Only DNMT3A mutations were statistically significantly associated with a high response rate prior to alloSCT (ORR 100%, CR/CRi 63%, p=0.01).
Secondary therapy:
azacitidine; cytarabine; decitabine
DOI:
10.1182/blood-2020-137749
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Long-Term Follow-Up of a Phase 1/2 Study of Venetoclax (VEN) Plus LowDose Cytarabine (LDAC) in Previously Untreated Older Adults with Acute Myeloid Leukemia (AML)

Published date:
09/14/2020
Excerpt:
At median 3.5-yr follow-up, VEN+LDAC resulted in median OS of 10 mo. At 2 yrs, 22% of study population remained alive; 32%, 36%, and 64% were alive with IDH1/2, de novo, or NPM1 mutant AML, respectively.
Secondary therapy:
cytarabine
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

LONG-TERM FOLLOW-UP OF A PHASE 1/2 STUDY OF VENETOCLAX PLUS LOW-DOSE CYTARABINE IN PREVIOUSLY UNTREATED OLDER ADULTS WITH ACUTE MYELOID LEUKEMIA

Published date:
06/12/2020
Excerpt:
In a phase 1/2 study, the potent BCL-2 inhibitor venetoclax (VEN)...Longer median OS was observed in pts who had mutations in NPM1 or IDH1/2 (not reached and 15.9 mo, respectively)…
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

TIMING OF RESPONSE TO VENETOCLAX COMBINATION TREATMENT IN OLDER PATIENTS WITH ACUTE MYELOID LEUKEMIA

Published date:
06/12/2020
Excerpt:
...Patients with baseline IDH1/2 and NPM1 mutations were more likely to achieve CR/CRi in ≤2 cycles as 67% (29/43) and 62% (16/26) with baseline IDH1/2 and NPM1 mutations achieved CR/CRi in ≤2 cycles of treatment respectively. Median duration of response was 21.2 months (95% CI: 14.1 – not estimable) for ≤2 cycle responders and 8.1 months (95% CI: 5.3 – 14.9) for >2 cycle responders.
Secondary therapy:
cytarabine; decitabine; azacitidine
Evidence Level:
Sensitive: C3 – Early Trials
Source:
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
DOI:
10.1182/blood-2018-99-114243
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Efficacy and Biological Correlates of Response in a Phase 2 Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia

Excerpt:
...Of these, 5 patients achieved a CR/CRi as a best objective response (3/5 patients had IDH1/2 mutation and none had FLT3-ITD mutation)...Venetoclax demonstrated activity and acceptable tolerability in patients with AML and adverse features.
DOI:
10.1158%2F2159-8290.CD-16-0313
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

Response to Venetoclax in Combination with Low Intensity Therapy (LDAC or HMA) in Untreated Patients with Acute Myeloid Leukemia Patients with IDH, FLT3 and Other Mutations and Correlations with BCL2 Family Expression

Excerpt:
The CR/CRi rates were 83.7% for pts with IDH1/IDH2 mutations, 84.6% for pts with NPM1 mutations, 59.5% for pts with TP53 mutations, and 53.3% for pts with FLT3 mutations (Table 2)….VEN + HMA or LDAC has efficacy across multiple molecular markers in AML
Secondary therapy:
cytarabine
DOI:
https://doi.org/10.1182/blood-2019-128373
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

Anti-Leukemic Activity of Single Agent Venetoclax in Newly Diagnosed Acute Myeloid Leukemia: A Sub-Set Analysis of the Caveat Study

Published date:
11/06/2019
Excerpt:
Treatment naïve NPM1 and IDH2 mutant AML blasts are highly sensitive to VEN alone and combination with cytarabine and anthracycline chemotherapy results in a high clinical response rate. TP53 and FLT3-ITD mutant cases were more resistant and outcomes were poor despite VEN combined with chemotherapy.
Secondary therapy:
cytarabine
DOI:
0.1182/blood-2019-126640
Evidence Level:
Sensitive: D – Preclinical
Source:
Title:

Anti-Leukemic Activity of Single Agent Venetoclax in Newly Diagnosed Acute Myeloid Leukemia: A Sub-Set Analysis of the Caveat Study

Published date:
11/06/2019
Excerpt:
Treatment naïve NPM1 and IDH2 mutant AML blasts are highly sensitive to VEN alone and combination with cytarabine and anthracycline chemotherapy results in a high clinical response rate. TP53 and FLT3-ITD mutant cases were more resistant and outcomes were poor despite VEN combined with chemotherapy.
DOI:
10.1182/blood-2019-126640