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AboutTALZENNA MoATalzenna MoAgBRCA testingIdentifying patientsGuidelinesStudy designStudy designBaseline characteristicsEfficacy & SafetyTALZENNA efficacyPrimary endpoint & subgroup analysisSecondary endpoints: ORRSecondary endpoint: OSExploratory endpoints: DoR & TTRTALZENNA safetySafety and tolerabillityAdverse eventsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesPrescribing InformationSupport & ResourcesSupport & ResourcesMaterialsElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
EMBRACA Study - Efficacy Superior to chemotherapy in delaying disease progression1*†Median PFS was significantly improved with TALZENNA® vs chemotherapy.
  • Median PFS of 8.6 months with TALZENNA® – significantly longer than 5.6 months with chemotherapy1
Adapted from TALZENNA® SmPC. N Engl J Med 2018, 2 and data on file.337% of TALZENNA® patients and 20% of chemotherapy patients did not have disease progression or death at 1 year, as determined by independent review2Consistent PFS results were observed across prespecified subgroups defined by study stratification factors1-3*‡§Adapted from TALZENNA SmPC.PFS significantly improved vs chemotherapy in patients with TNBC, HR+ disease, and history of CNS metastases4,5*§
  • All predefined subgroups below showed a PFS benefit in favor of TALZENNA®
Adapted from Rugo et al. JNCI Cancer Spectr. 2020.5
ABC=advanced breast cancer; BRCA=breast cancer susceptibility gene; Cl=confidence interval; CNS=central nervous system; DoR=duration of response; gBRCA=germline breast cancer susceptibility gene; GHS=global health status; HER2-=human epidermal growth factor receptor 2 negative; HR=hazard ratio; HR+=hormone receptor-positive; ITT=intent-to-treat; LA/mBC=locally advanced/metastatic breast cancer; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; QoL=quality of life; RECIST=Response Evaluation Criteria in Solid Tumors; TNBC=triple-negative breast cancer; TTR=time to response.PFS was determined by blinded independent central review (BICR), according to RECIST v1.1. Capecitabine, eribulin, gemcitabine, or vinorelbine.Study stratification factors include hormone receptor-expression status, BRCA mutation type, visceral/nonvisceral metastases, and with/without a history of CNS metastasis. Depicts subgroup analyses from the overall EMBRACA study population. Small patient numbers can be a limitation of subgroup analyses.  Explore more Secondary endpoints
References:TALZENNA® Summary of Product Characteristics. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018;379(8):753-763.Data on file. Pfizer Inc., New York, NY.Eiermann W, Rugo HS, Diab S, et al. Analysis of germline BRCA1/2 mutated (gBRCAm) hormone receptor-positive (HR+) and triple-negative breast cancer (TNBC) treated with talazoparib (TALA). Poster presented at: Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2018; Chicago, IL. Poster 1070.Rugo HS, Ettl J, Hurvitz SA, et al. Outcomes in clinically relevant patient subgroups from the EMBRACA study: talazoparib vs physician's choice standard-of-care chemotherapy. JNCI Cancer Spectr. 2020;4(1):1-12.
Litton JK, Hurvitz SA, Mina LA, et al. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020;31(11):1526-1535.

Legal Category: S1A 
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PP-TAL-IRL-0108 May 2024
TALZENNA efficacy Improved patient-reported outcomes

Significant improvements in GHS/QoL and breast symptoms6

 See the results  Appropriate patients for TALZENNA®

Meets the needs of patients with gBRCA-mutated HR+/HER2- or triple-negative LA/mBC1

 View patient profiles
TALZENNA Summary of Product Characteristics Product CharacteristicsLoading

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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