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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Breast Cancer |
| Drug: | Talzenna (talazoparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline
Published date:
04/03/2020
Excerpt:
Recommendations...Poly (ADP-ribose) polymerase (PARP) inhibitors (olaparib and talazoparib) are preferable to nonplatinum single-agent chemotherapy for treatment of advanced BC in BRCA1/2 carriers.
DOI:
10.1200/JCO.20.00299
Source:
Excerpt:
Biomarkers associated with FDA-approved therapies...While olaparib and talazoparib are FDA indicated in HER2-negative disease, the panel supports use in any breast cancer subtype associated with a germline BRCA1 or BRCA2 mutation.
Source:
Title:
272P - Outcomes of patients (pts) who had received prior platinum (PP) therapy in the phase III EMBRACA trial of talazoparib (TALA) vs physician’s choice of chemotherapy (PCT) in patients with germline BRCA1/2 mutated (gBRCA1/2mut) advanced breast cancer (ABC)
Published date:
09/13/2021
Excerpt:
Outcomes of patients (pts) who had received prior platinum (PP) therapy in the phase III EMBRACA trial of talazoparib (TALA) vs physician’s choice of chemotherapy (PCT) in patients with germline BRCA1/2 mutated (gBRCA1/2mut) advanced breast cancer (ABC)...Efficacy outcomes generally favored TALA over PCT in the PP subgroup in both early- and late-stage settings but were particularly favorable for pts who received PP as neoadj/adj treatment.
Trial ID:
Source:
Title:
Outcomes in Clinically Relevant Patient Subgroups From the EMBRACA Study: Talazoparib vs Physician's Choice Standard-of-Care Chemotherapy
Published date:
04/28/2020
Excerpt:
Across all patient subgroups with gBRCA-mutated advanced breast cancer, talazoparib demonstrated clinically significant superiority in outcomes compared with PCT.
DOI:
10.1093/jncics/pkz085
Trial ID:
Source:
Title:
2279 - EMBRACA: Comparison of efficacy and safety of talazoparib (TALA) and physician's choice of therapy (PCT) in patients (pts) with advanced breast cancer (aBC), a germline BRCA1/2 mutation (gBRCAm), and prior platinum treatment
Published date:
10/22/2018
Excerpt:
TALA demonstrated a statistically significant improvement in both objective response rate (odds ratio [OR] [95% CI]: PP 3.16 [0.88-15.67], P=.0456; NPP 5.36 [2.89-9.89], P<.0001) and progression-free survival (hazard ratio [95% CI]: PP 0.76 [0.40-1.45], P=.41; NPP 0.52 [0.39-0.71], P<.0001) compared with PCT....In pts with advanced gBRCAm breast cancer, TALA demonstrated statistically significant improvements in clinical outcomes for both PP and NPP subgroups compared with PCT.
DOI:
10.1093/annonc/mdy272
Trial ID:
Source:
Title:
Exposure-efficacy progression-free survival (PFS) analyses of breast cancer patients with germline BRCA1/2 mutations receiving talazoparib in the phase III EMBRACA trial
Published date:
10/01/2018
Excerpt:
A diseasefree interval of > 12 months was associated with a longer PFS than that of ≤ 12 months….PFS was found to be associated with Cavg,t, and a longer PFS was associated with a higher talazoparib exposure.
DOI:
https://doi.org/10.1093/annonc/mdy272.295
Trial ID:
Source:
Title:
EMBRACA: Efficacy and safety in comparing talazoparib (TALA) with physician's choice of therapy (PCT) in patients (pts) with advanced breast cancer (aBC) and a germline BRCA mutation (gBRCAm); BRCA1/BRCA2 subgroup analysis
Published date:
10/01/2018
Excerpt:
TALA demonstrated a statistically significant improvement in both objective response rate (odds ratio [OR] [95% CI] BRCA1 7.01 [2.99-19.54]…and progression-free survival (hazard ratio [95% CI] BRCA1 0.59 [0.39-0.90]…in BRCA1 and BRCA2 subgroups compared with PCT…
DOI:
https://doi.org/10.1093/annonc/mdy272.294
Trial ID:
Source:
Title:
EMBRACA: Efficacy outcomes in clinically relevant subgroups comparing talazoparib (TALA), an oral poly ADP ribose polymerase (PARP) inhibitor, to physician's choice of therapy (PCT) in patients with advanced breast cancer and a germline BRCA mutation.
Published date:
05/16/2018
Excerpt:
...pts with advanced breast cancer (aBC) and a germline BRCA1/2 mutation (gBRCAmut). Of 431 pts randomized, 287 were assigned to receive TALA and 144 to PCT. PFS and ORR are shown (Table).
DOI:
10.1200/JCO.2018.36.15_suppl.1069
Trial ID:
Source:
Title:
Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation
Excerpt:
Our phase 3 trial (EMBRACA) compared the efficacy and safety of talazoparib with standard chemotherapy of the physician’s choice for the treatment of locally advanced or metastatic breast cancer in patients with a germline BRCA1/2 mutation...The median progression-free survival among patients in the talazoparib group was longer than that among patients in the standard-therapy group (8.6 months [95% confidence interval {CI}, 7.2 to 9.3] vs. 5.6 months [95% CI, 4.2 to 6.7]....
DOI:
10.1056/NEJMoa1802905
Trial ID:
Title:
Regulator OKs Pfizer's BRCA mutation breast cancer treatment
Excerpt:
Pfizer Korea said that the Ministry of Food and Drug Safety has approved Talzenna, its BRCA (Breast Cancer Susceptibility Gene) mutation breast cancer targeted therapy....treatment as monotherapy for germline BRCA (gBRCA) mutations and HER2 (human epithelial cell growth factor receptor 2) negative locally advanced or metastatic breast cancer patients have previously had chemotherapy.
Source:
Title:
A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study) (ABRAZO)
Excerpt:
...Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation...
Trial ID:
Source:
Title:
Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors
Excerpt:
...Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease...
Trial ID:
Less C2 evidence
Source:
Title:
Genomic analysis of advanced breast cancer tumors from talazoparib-treated gBRCA1/2mut carriers in the ABRAZO study
Published date:
10/06/2023
Excerpt:
In this genomic analysis of the ABRAZO trial, we demonstrate that tumor-only BRCA1/2 sequencing has high sensitivity for gBRCA1/2mut....A significant association was observed between the number of DDR alterations (two vs one) and best response to talazoparib in Cohort 2, with single mutations being associated with higher responsiveness...
DOI:
10.1038/s41523-023-00561-y
Trial ID:
Source:
Title:
124P - Talazoparib in Local Advanced or Metastatic Breast Cancer Patients: Experience from an Early Access Program in Turkey
Published date:
05/03/2021
Excerpt:
...advanced breast cancer patients with BRCA1 or BRCA2 mutation who received Talazoparib treatment via early access program were retrospectively analyzed....The objective response rate (ORR) was 31.9% (n=15) and disease-control rate was 61.7% (n=29). In 10.6% of patients complete response was achieved with Talazoparib treatment.
Source:
Title:
Phase I, Dose-Escalation, Two-Part Trial of the PARP Inhibitor Talazoparib in Patients with Advanced Germline BRCA1/2 Mutations and Selected Sporadic Cancers
Excerpt:
In this clinical trial, we show that talazoparib has single-agent antitumor activity and a tolerable safety profile. At its recommended phase II dose of 1.0 mg/day, confirmed responses were observed in patients with BRCA mutation-associated breast and ovarian cancers and in patients with pancreatic and small cell lung cancer.
DOI:
10.1158/2159-8290.CD-16-1250
Trial ID:
