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Association details:
| Biomarker: | TP53 deletion |
|---|---|
| Cancer: | Chronic Lymphocytic Leukemia |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) + Gazyva (obinutuzumab) (CD20 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL
Excerpt:
...Subjects must have TP53 deletion (17p-) and/or mutation (in bone marrow or peripheral blood), with pre-existing local test results confirmed by central laboratory in Ulm 4....
Trial ID:
Source:
Title:
Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study
Published date:
10/06/2023
Excerpt:
PFS remained superior for Ven-Obi compared to Clb-Obi (median 76.2 vs. 36.4 months; hazard ratio [HR] 0.40 [95% CI 0.31–0.52], p<0.0001)…Multivariate analysis identified TP53 deletion/mutation, unmutated IGHV and lymph node size ≥5cm as independent negative prognostic factors for PFS in patients treated with Ven-Obi...These long-term data confirm a continued PFS benefit of fixed-duration Ven-Obi treatment compared to Clb-Obi, including patients with high-risk CLL.
Source:
Title:
137 | Venetoclax-Obinutuzumab for previously untreated chronic lymphocytic leukemia: 4-year follow-up analysis of the randomized CLL14 study
Published date:
06/09/2021
Excerpt:
Pts with previously untreated CLL and coexisting conditions were randomized 1:1 to receive 12 cycles of Ven with 6 cycles of Obi or 12 cycles of Clb with 6 cycles of Obi....At 4 years after randomization, the estimated PFS rate was 74.0% in the Ven-Obi arm and 35.4% in the Clb-Obi arm. This improvement was observed across all clinical and biological risk groups, including pts with TP53 mutation/deletion (4-year PFS 53.0% vs 20.8%)...
