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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....
Source:
Title:
2020 Low-Dose Venetoclax-Dexamethasone in t(11;14) Positive Relapsed and Refractory Multiple Myeloma; Interim Results from the Ongoing, Danish, Investigator-Initiated, Open Label, Phase 2 Victoria Study
Published date:
11/02/2023
Excerpt:
Based on this interim analysis, low-dose VEN-DEX in patients with RRMM and t(11;14) has a convenient safety profile and an efficacy comparable to previously tested VEN and VEN-DEX regimens with higher VEN doses.
Secondary therapy:
dexamethasone
Source:
Title:
Venetoclax in biomarker-selected multiple myeloma patients: Impact of exposure on clinical efficacy and safety
Published date:
09/23/2023
Excerpt:
These findings support further study of venetoclax at 800 mg QD dose in combination with dexamethasone in the t(11;14)-positive patient population where increased efficacy was observed without an increase in safety events.
Secondary therapy:
dexamethasone
DOI:
10.1002/hon.3222
Trial ID:
Source:
Title:
Venetoclax-based salvage in multiple myeloma with (11;14) translocation after suboptimal response to first-line therapy
Published date:
06/11/2023
Excerpt:
We have shown that when salvage is needed for t(11;14) patients who respond suboptimally to standard frontline therapy, venetoclax is a remarkably good option.
DOI:
10.1556/650.2023.32790
Source:
Title:
Association of venetoclax-based therapy with increased survival in multiple myeloma (MM) harboring t(11;14): A single-center experience.
Published date:
05/25/2023
Excerpt:
We retrospectively identified all t(11;14) MM patients….Median unadjusted OS was longer in the Ven group (206 months [95% CI, 112-249 months] vs 75 months [95% CI, 65-97 months]; p < 0.01)….Ven was associated with a reduced risk of death (HR, 0.26; 95% CI, 0.15-0.47). Of 73/78 with available response data, 38% achieved ≥VGPR with Ven-based therapy. Median PFS was 27 months (95% CI, 13-39 months)....In this real world dataset, MM patients with t(11;14) treated with Ven-based combinations exhibited superior survival.
DOI:
10.1200/JCO.2023.41.16_suppl.e20055
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:
Patients with t(11;14) had superior ORR [relative risk (RR) = 1.47, 95% CI = 1.05-2.07], ≧VGPR (RR = 1.71, 95% CI = 1.12-2.60), CR (RR = 1.86, 95% CI = 1.34-2.57), PFS [hazard ratio (HR) = 0.47, 95% CI = 0.30-0.65], and OS (HR = 0.30, 95% CI = 0.08-0.52) compared with patients without t(11;14)...Venetoclax-based therapy is an effective and safe option for RRMM patients, especially those with t(11;14).
DOI:
10.1177/20406207231155028
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
DOI:
https://doi.org/10.1182/blood-2022-166584
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.
