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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | veliparib (ABT-888) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
5426 / 9 - Multi-omic characterization and predictive features of advanced ovarian cancer patients in a large phase III cohort Add to My Itinerary
Published date:
03/15/2023
Excerpt:
800+ advanced ovarian cancer patients enrolled in the phase III trial of the PARP-1 inhibitor Veliparib (VELIA)….Pairwise analysis of individual features with clinical outcomes shows that increased tumor-mutation burden (TMB)...were each significantly associated with longer PFS and less progressive disease (PD). Similarly, homologous recombination deficiency (HRD) and BRCA alteration were associated with better clinical outcomes, while high CA-125 was associated with worse outcomes.
Source:
Title:
Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer
Excerpt:
In the BRCA-mutation cohort, the median progression-free survival was 34.7 months in the veliparib-throughout group and 22.0 months in the control group (hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.28 to 0.68; P<0.001)...
DOI:
10.1056/NEJMoa1909707
Trial ID:
Source:
Title:
Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (VELIA)
Excerpt:
...Participant has one of the following available for pharmacodynamic analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1...Progression-Free Survival (PFS) in the BRCA-deficient Population...
Trial ID:
Source:
Title:
A phase 1 and pharmacodynamic study of chronically-dosed, single-agent veliparib (ABT-888) in patients with BRCA1- or BRCA2-mutated cancer or platinum-refractory ovarian or triple-negative breast cancer
Published date:
04/18/2022
Excerpt:
This phase I study determined the recommended phase II dose (RP2D) and preliminary efficacy of the PARP inhibitor, veliparib (ABT-888), in these patients....Overall response rate (ORR) was 23% (95% CI 13-35%) in BRCAmut overall, and 37% (95% CI 21-55%) at 400 mg BID and above....There is evidence of clinical activity of veliparib in patients with BRCAmut and BRCAwt cancers.
DOI:
10.1007/s00280-022-04430-6
Source:
Title:
PFS by blinded independent central review (BICR) in the VELIA trial of veliparib (V) plus carboplatin/paclitaxel (CP) and as monotherapy in newly diagnosed patients (pts) with high-grade serous ovarian cancer (HGSC).
Published date:
05/13/2020
Excerpt:
Analyses of PFS per BICR supported the primary analysis of PFS per INV in the BRCAm, HRD, and whole populations, as well as exploratory BRCAwt and non-HRD populations. Median PFS per BICR was longer compared to PFS per INV assessments in all populations and in both arms.
Secondary therapy:
carboplatin + paclitaxel
DOI:
10.1200/JCO.2020.38.15_suppl.6077
Trial ID:
