^
Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
12/04/2016
Excerpt:
Venclyxto monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor.
Source:
Title:
Venetoclax for treating chronic lymphocytic leukaemia
Published date:
06/15/2022
Excerpt:
Venetoclax monotherapy is recommended, within its marketing authorisation, for treating chronic lymphocytic leukaemia (CLL) in adults with a 17p deletion or TP53 mutation and when a B-cell receptor pathway inhibitor is
unsuitable, or whose disease has progressed after a B-cell receptor pathway inhibitor.
Source:
Excerpt:
Suggested treatment regimens...CLL/SLL with del(17p)/TP53 mutation…Relapsed/refractory therapy…preferred regimen…Venetoclax
Source:
Title:
Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Excerpt:
Recommendations: TP53 mutation or del(17p): ibrutinib or acalabrutinib or venetoclax plus obinutuzumab or venetoclax alone or idelalisib plus rituximab [III, A].
DOI:
10.1016/j.annonc.2020.09.019
Source:
Title:
EFFICACY OF VENETOCLAX IN PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA: PRIMARY ENDPOINT ANALYSIS OF THE INTERNATIONAL PHASE 3B TRIAL (VENICE I)
Published date:
06/12/2020
Excerpt:
PFS in mos (24 mos PFS estimate %) was 30.5 (77.0%) overall, 28.6 (67.1%) in patients with 17p/TP53 aberration, and 30.5 (79.4%) vs 28.6 (69.9%) for the BCRi-N vs BCRi-EXP groups.
Trial ID:
Source:
Title:
VENETOCLAX IMPROVES QUALITY OF LIFE FOR PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
Published date:
05/17/2018
Excerpt:
This is an open-label, phase 3b, multicenter study (NCT02980731)…Patients were ≥18 years old with R/R CLL, including those with 17p deletion, TP53 mutations, and/or prior experience with B-cell receptor inhibitor-containing (BCRi) therapy, treated with Ven monotherapy....Clinically meaningful improvements in global health status, role functioning and fatigue were observed as early as week 12 post-treatment.
Trial ID:
Source:
Title:
Evaluation of Risk-Adapted and MRD-Driven Strategy for Untreated Fit Patients With Intermediate Risk Chronic Lymphocytic Leukemia
Excerpt:
...- Absence of 17p deletion and/or TP53 mutation....
Trial ID:
Source:
Title:
A Study Evaluating the Impact of Venetoclax on the Quality of Life for Subjects With Relapsed (Your Cancer Has Come Back) or Refractory (no Response to Previous Cancer Treatments) Chronic Lymphocytic Leukemia (CLL) While Receiving Venetoclax Monotherapy (a Single Agent).
Excerpt:
...- with or without 17p deletion or TP53 mutation...
Trial ID:
More C2 evidence
Source:
Title:
Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting
Excerpt:
...- Venetoclax monotherapy for the treatment of CLL in the presence of deletion chromosome 17 (del[17p]) or tumor protein p53 (TP53) mutation in adult participants, who are unsuitable for or have failed to a B-cell receptor pathway inhibitor....
Trial ID:
Source:
Title:
A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)
Excerpt:
...- with or without 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood are eligible...
Trial ID:
Less C2 evidence
Source:
Title:
SAFETY AND EFFECTIVENESS OF VENETOCLAX MONOTHERAPY IN R/R CLL PATIENTS WITH OR WITHOUT RISK-ASSOCIATED GENETIC MARKERS – DATA FROM THE OBSERVATIONAL VERVE STUDY
Published date:
05/12/2022
Excerpt:
CLL patients included in this study required therapy and were eligible for Ven monotherapy treatment according to local label.... the best ORR (CR/CRi) was 76% (43%) in patients with TP53 aberrations and 69% (27%) in patients without TP53 aberrations. When subdivided according to IGHV status, the best ORR (CR/CRi) was 83% (33%) in IGHV mutated...CR/CRi rates were highest in patients with TP53 aberration or IGHV unmutated patients.
Source:
Title:
REAL-WORLD EFFICACY AND SAFETY OF VENETOCLAX IN CHRONIC LYMPHOCYTIC LEUKAEMIA – FIRST DATA FROM THE VERONE STUDY, IN PATIENTS WITH VENETOCLAX MONOTHERAPY
Published date:
05/12/2021
Excerpt:
...Del(17p), 15.0%; TP53 mutation…In the 62 patients of the evaluable population, the 1-year ORR was 85.5% [95% CI 76.7% - 94.3%]. Considering the median follow-up of patients of 13.1 months, the 1-year estimate for PFS was 80.2% [95% CI 68.8% - 88.6%].... V monotherapy is effective in non-selected pre-treated CLL patients, with similar outcomes as compared to clinical trials.
Trial ID:
Source:
Title:
MINIMAL RESIDUAL DISEASE-DRIVEN TREATMENT INTENSIFICATION WITH SEQUENTIAL ADDITION OF IBRUTINIB (IBR) TO VENETOCLAX (VEN) IN RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): THE IMPROVE STUDY
Published date:
05/12/2021
Excerpt:
...8/33 (24%) carried del(17p); 10/30 (33%) TP53 mutations, and 24/30 (80%) unmutated IGHV….overall response rate with VEN mono was 36/38 (95%), 19 CR and 17 PR….
