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Association details:
| Biomarker: | Chr t(11;14) |
|---|---|
| Cancer: | Multiple Myeloma |
| Drug: | Venclexta (venetoclax) (Bcl2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
Multiple Myeloma: Therapy for previously treated multiple myeloma…Useful In Certain Circumstances… Venetoclax/dexamethasone only for t(11;14) patients
Source:
Title:
Study of Venetoclax in Combination With Carfilzomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma (MM)
Excerpt:
...- Positive for translocation t(11;14) as determined by an analytically validated Fluorescent In Situ Hybridization (FISH) assay per central laboratory testing....
Trial ID:
Source:
Title:
Efficacy and safety of venetoclax-based regimens for the treatment of relapsed/refractory multiple myeloma: a systemic review and meta-analysis
Published date:
03/06/2023
Excerpt:
This meta-analysis aimed to investigate the efficacy and safety of venetoclax-based therapy in RRMM….The pooled ORR, rate of ≧VGPR, and CR for all patients were 59% [95% confidence interval (CI) = 45-71%], 38% (95% CI = 26-51%), and 17% (95% CI = 10-26%), respectively....Venetoclax-based therapy is an effective and safe option for RRMM patients, especially those with t(11;14).
Source:
Title:
1864 Impact of Venetoclax Exposure on Clinical Efficacy and Safety in Biomarker-Selected Patients with Relapsed or Refractory Multiple Myeloma: Implication for Dose Selection
Published date:
11/03/2022
Excerpt:
VenDex was only administered in t(11;14)-positive subjects...cumulative logistic regression analyses for clinical response rates (stable disease or better [≥SD], partial response or better [≥PR], and very good partial response or better [≥VGPR]) demonstrated a statistically significant (p<0.05) relationship with venetoclax exposure in the t(11;14)-positive subpopulation.... In t(11;14)-positive R/R MM subjects, higher venetoclax exposures resulted in improved efficacy without an increase in safety events compared to lower exposures.
Secondary therapy:
dexamethasone
Trial ID:
Source:
Title:
Venetoclax for the Treatment of Multiple Myeloma: Outcomes Outside of Clinical Trials
Published date:
06/11/2021
Excerpt:
We reviewed the medical records of relapsed and/or refractory MM patients…The presence of t(11;14) was associated with improved PFS (median 9.7 months vs. 4.2 months, p=0.019) and OS (median not reached vs. 10.8 9 months, p=0.015)….Venetoclax demonstrates encouraging activity in heavily-treated patients with relapsed/refractory MM, particularly t(11;14) patient-population.
DOI:
10.1002/ajh.26269
Source:
Title:
Targeting BCL-2 with venetoclax and dexamethasone in patients with relapsed/refractory t(11;14) multiple myeloma
Published date:
12/28/2020
Excerpt:
VenDex demonstrated efficacy and manageable safety in heavily-pre-treated patients with t(11;14) R/R MM.
Secondary therapy:
dexamethasone
DOI:
10.1002/ajh.26083
Source:
Title:
Efficacy of Venetoclax Based Regimens in Relapsed Refractory Multiple Myeloma: A Systematic Review and Meta-Analysis
Published date:
11/04/2020
Excerpt:
The pooled overall response rate (ORR) for all patients who received venetoclax (n=466) was 57% (95% confidence interval (CI) 0.34-0.77, p<0.01; I2=95%)…VEN is an effective treatment option for relapsed and refractory multiple myeloma patients with t(11:14) translocation. The overall response rate and the duration of response are better in patients with t(11:14).
DOI:
10.1182/blood-2020-142054
Source:
Title:
Targeting Bcl-2 Proteins in Myeloma
Published date:
11/06/2019
Excerpt:
A phase 1 clinical trial of venetoclax in relapsed/refractory myeloma patients demonstrate its efficacy mainly in t(11;14) patients with 40% of overall response.
DOI:
https://doi.org/10.1182/blood-2019-121103
Source:
Title:
VENETOCLAX MONOTHERAPY AND COMBINED WITH DEXAMETHASONE AS TARGETED THERAPY FOR RELAPSED/REFRACTORY T(11;14) MULTIPLE MYELOMA
Published date:
05/17/2018
Excerpt:
...pts received Ven once daily as monotherapy (n=30; 300, 600, 900, 1200mg) or Ven 800mg + Dex 40mg (n=20)....On Ven + Dex, ORR was 65% (13/20; 35% had ≥VGPR)...Ven monotherapy and Ven + Dex had tolerable and comparable safety profiles in these heavily pre-treated pts. With ORR of 40% with Ven monotherapy and 65% with Ven + Dex, these results confirm the efficacy of Ven in pts with t(11;14) MM and support ongoing study of Ven + Dex.
Secondary therapy:
dexamethasone
Source:
Title:
Ex Vivo Drug Sensitivity and Functional Genomics Platform Identifies Novel Combinations Targeting Intrinsic and Extrinsic Apoptotic Signaling Pathways in Multiple Myeloma
Published date:
11/04/2020
Excerpt:
...t(11;14)-positive MM patient specimens were more sensitive than wildtype to Ven ex vivo (D AUC, -18.6, P=0.002), however MM cells harboring amp(1q) were more resistant than wildtype (D AUC, +5.07, P=0.032), suggesting MCL1 (1q21 gene locus) is a key resistance factor to Ven single-agent activity in MM.
