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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Chronic Myelomonocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) |
| Direction: | Sensitive |
Evidence:
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 to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS
Excerpt:
...Mutated P53 or Ras pathway genes (CBL, NRAS, KRAS, NF1, PTPN1) or DNMT 3a or ASXL1 or RUNX1 3....
Trial ID:
Source:
Title:
Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN
Excerpt:
...- Presence of a mutation in TP53...
Trial ID:
More C2 evidence
Source:
Title:
Venetoclax and Decitabine in Treating Participants With Relapsed/Refractory Acute Myeloid Leukemia or Relapsed High-Risk Myelodysplastic Syndrome
Excerpt:
...- Patients with newly diagnosed AML with poor risk complex karyotype and/or TP53 deletions/mutations equal or younger than 60 year old...
Trial ID:
Less C2 evidence
Source:
Title:
3131 Continuous Venetoclax in Previously Untreated Patients with Chronic Lymphocytic Leukemia and TP53 Abnormalities. a Study of the Italian Campus CLL
Published date:
11/03/2022
Excerpt:
Thirty-four TN CLL with TP53 abnormalities were recruited….The best ORR was 85%, including 50% complete responses (CR) and 35% partial responses (PR) (Fig. 1)….The 12 and 24-month PFS were 96% and 83%, respectively (Fig. 1). All patients were alive after 12 months and the estimated 24-month OS was 88%....Compared to patients treated with ibrutinib (n=100 , comparable for age and comorbidities, median follow-up 24months), we observed a higher CR rate (50% vs 9%, p<0.0001), a trend for a longer PFS (p=0.10) and a lower incidence of discontinuation (24-month 14% vs 35%, p=0.0194) in patients receiving venetoclax (Fig. 1)...we report the largest real-life study of continuous venetoclax in TN CLL patients with TP53 abnormalities, indicating a high efficacy of venetoclax in this subset of patients...
DOI:
https://doi.org/10.1182/blood-2022-159334
Source:
Title:
A Phase I/II Study of Venetoclax in Combination With ASTX727 (Decitabine/Cedazuridine) in Treatment-Naïve High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)
Published date:
09/21/2022
Excerpt:
The ORR was 95% with 3 pts achieving CR (16%) and 15 pts achieving marrow CR (79%). All pts achieved a response within 1 cycle among which 7 pts, including one with TP53mut, proceeded to hematopoietic stem cell transplant...Ven+ASTX727 combination appears safe and demonstrates preliminary efficacy in pts with higher risk MDS or CMML with excess blasts. Total-oral regimen of Ven+ASTX727 combination appears to be a promising strategy for high-risk MDS or CMML pts.
Secondary therapy:
decitabine/cedazuridine
Trial ID:
Source:
Title:
A PHASE I/II STUDY OF VENETOCLAX IN COMBINATION WITH ASTX727 (DECITABINE/CEDAZURIDINE) IN TREATMENT‐NAÏVE HIGH‐RISK MYELODYSPLASTIC SYNDROME (MDS) OR CHRONIC MYELOMONOCYTIC LEUKEMIA (CMML)
Published date:
05/12/2022
Excerpt:
All pts achieved a response within 1 cycle among which 4 pts, including one with TP53mut...Ven+ASTX727 combination appears safe and demonstrates preliminary efficacy in pts with higher risk MDS or CMML…
Secondary therapy:
decitabine/cedazuridine
Trial ID:
