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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 ProfilesSupport & 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 
Further information is available upon request

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)
 

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