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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Imbruvica (ibrutinib) (BTK inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
08/30/2022
Excerpt:
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma...SUGGESTED TREATMENT REGIMENS...CLL/SLL with del(17p)/TP53 mutation…Other recommended regimens…Ibrutinib + venetoclax…
Source:
Title:
Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia
Excerpt:
...- Cohort 2: Untreated patients with high-risk features (del(17p), or mutated TP53, or del(11q), or unmutated IGHV, or >= 65 years of age) are eligible (cohort 2) provided they have active disease requiring treatment as defined by the International Working Group for CLL (IWCLL)...
Trial ID:
Source:
Title:
Ibrutinib lead-in Followed by Venetoclax Plus Ibrutinib in Patients With RR CLL
Excerpt:
...- Cytologically and immunophenotypically confirmed relapsed/refractory CLL (irrespective of the 17p deletion and/or TP53 mutation status and the duration of remission from last prior therapy)...
Trial ID:
Less C2 evidence
Source:
Title:
4635 Combined Ibrutinib and Venetoclax for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia (CLL): 5-Year Follow-up Data
Published date:
11/02/2023
Excerpt:
We report long term follow-up of combined IBR and VEN in first-line CLL (n=120) with a 5-year PFS of 90.1%. The 5-year PFS for pts with del(17p)/TP53 mutation is 86.1%. Retreatment with BTK inhibitor appears effective for pts with disease relapse.
Source:
Title:
Fixed-duration ibrutinib + venetoclax for first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): 4-y follow-up from the FD cohort of the phase 2 CAPTIVATE study.
Published date:
05/25/2023
Excerpt:
Pts aged ≤70 y with previously untreated CLL/SLL received 3 cycles of I then 12 cycles of I+V (I 420 mg/d orally; V ramp-up to 400 mg/d orally)….4 y PFS rates were numerically lower in pts with uIGHV (73%) or del(17p) and/or TP53 mutation (63%), while OS rates remained consistently high (Table)....With 4 y follow-up, fixed-duration I+V continues to provide deep, durable remissions with clinically meaningful PFS and time off treatment, including in pts with high-risk disease features.
DOI:
10.1200/JCO.2023.41.16_suppl.7535
Trial ID:
Source:
Title:
Ibrutinib Plus Venetoclax for First-line Treatment of Chronic Lymphocytic Leukemia
Published date:
06/10/2021
Excerpt:
Patients were required to have at least 1 of the following features: del(17p), TP53-mutated CLL, del(11q)...Therapy consisted of ibrutinib, 420 mg/d, monotherapy for 3 cycles, thereafter combined with venetoclax....The 3-year progression-free survival was 93%, and 3-year overall survival was 96%....Remissions appeared to be durable during a follow-up of more than 3 years, with activity seen across high-risk disease subgroups, including those with del(17p)/TP53-mutated CLL.
DOI:
10.1001/jamaoncol.2021.1649
Trial ID:
Source:
Title:
032 | CAPTIVATE PRIMARY ANALYSIS OF FIRST-LINE TREATMENT WITH FIXED-DURATION IBRUTINIB PLUS VENETOCLAX FOR CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Published date:
06/09/2021
Excerpt:
Eligible pts were aged ≤70 y and had not received previous treatment for CLL/SLL. Pts received 3 cycles of I then 12 cycles of I+V (I 420 mg/d orally; V ramp-up to 400 mg/d orally)….In the 27 pts with del(17p)/TP53 mutation, CR rate was 56%...
DOI:
https://doi.org/10.1002/hon.2879
Trial ID:
Source:
Title:
Fixed-duration (FD) first-line treatment (tx) with ibrutinib (I) plus venetoclax (V) for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of the FD cohort of the phase 2 captivate study.
Published date:
05/21/2021
Excerpt:
In pts with del(17p)/TP53 mutation (n=27), CR rate was 56%, uMRD rate was 81% (PB) and 41% (BM), and 24-mo PFS was 84% (95% CI 63–94). Of 34 pts with high baseline TLS risk based on tumor burden, 32 (94%) shifted to medium or low risk after I lead-in; no TLS occurred....First-line I+V is an all-oral, once-daily, chemotherapy-free, fixed-duration regimen that provides deep, durable responses in pts with CLL/SLL, including those with genomic high-risk features.
DOI:
10.1200/JCO.2021.39.15_suppl.7501
Trial ID:
Source:
Title:
Fixed-duration (FD) first-line treatment (tx) with ibrutinib (I) plus venetoclax (V) for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): Primary analysis of the FD cohort of the phase 2 captivate study.
Published date:
05/19/2021
Excerpt:
In pts with del(17p)/TP53 mutation (n=27), CR rate was 56%, uMRD rate was 81% (PB) and 41% (BM), and 24-mo PFS was 84% (95% CI 63–94)….First-line I+V is an all-oral, once-daily, chemotherapy-free, fixed-duration regimen that provides deep, durable responses in pts with CLL/SLL, including those with genomic high-risk features.
DOI:
10.1200/JCO.2021.39.15_suppl.7501
Trial ID:
Source:
Title:
Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): Results from the MRD Cohort of the Phase 2 CAPTIVATE Study
Published date:
11/06/2019
Excerpt:
The high rates of BM uMRD were consistent across high-risk subgroups, including in pts with del(17p) (75%), del(17p) or TP53 mutation (70%), del(11q) (84%), complex karyotype (83%), and unmutated IGHV status (81%)...First-line treatment with Ibr + Ven represents an all oral, once-daily, chemotherapy-free regimen that provides high rates of uMRD in both PB and BM in pts with CLL.
DOI:
https://doi.org/10.1182/blood-2019-121424
Trial ID:
Source:
Title:
THE RESULTS OF THERAPY IN PATIENTS WITH B-CELL LYMPHOID MALIGNANCIES WITH MUTATIONS IN THE TP53 GENE
Published date:
05/12/2021
Excerpt:
...patient with CLL - in as a first-line therapy ibrutinib with venetoclax was administered before allo-HCT...Five out of 8 patients remain in complete remission of the disease without signs of GVHD with follow-up from 1 to 52 months.
