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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 eventsHaematologic/Nonhaematologic AEsPatient-reported outcomes with TALZENNAPatient-reported outcomesGHS/QoLBreast symptomsDosingDosingDose recommendation and special populationsDose modifications/managementPatient ProfilesSupport & ResourcesSupport & ResourcesMaterialsVideosElevateElevatePersonalising Breast Cancer TreatmentUnderstanding and Optimising PARP Inhibitors for mBCPARP Inhibitors in mBC: the role of Real World Evidence
EMBRACA is the largest Phase 3, open-label study of PARP inhibitor  monotherapy in gBRCA-mutated HER2- LA/mBC1-3Study design1,2,4Adapted from TALZENNA SmPC, and Litton et al., N Engl J Med 2018.2Primary endpoint:1,4
  • PFS defined as disease progression or death per RECIST v1.1, as assessed by BICR
Secondary endpoints included:1,4
  • Objective response rate (ORR), as assessed by investigator
  • Overall survival (OS)
  • Safety
Exploratory endpoints included:1,4
  • Duration of response (DoR) and time to response for objective responders
  • ORR subgroup analysis
  • Quality of life (QoL) assessed through patient-reported outcomes (PROs)
Broad range of patient types included in EMBRACA
  • EMBRACA included a broad range of prespecified patient populations, including TNBC, HR+/HER2- disease, age, with/without a history of CNS metastases, and visceral/nonvisceral disease2

Percentages shown are for the TALZENNA arm only. 

Additional inclusion criteria:1,5
  • Patients received 0, 1, 2, or 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease 
  • Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, locally advanced and/or metastatic setting 
  • Patients who had objective disease progression while receiving platinum chemotherapy for locally advanced or metastatic disease were excluded 
  • Patients who received low-dose platinum therapy administered in combination with radiation therapy were not excluded
  • Patients who received platinum therapy in the adjuvant or neoadjuvant setting were eligible; however, patients may not have relapsed within 6 months of the last dose of prior platinum therapy 
  • No prior treatment with a PARP inhibitor was permitted
BICR=blinded independent central review; CNS=central nervous system; gBRCA=germline breast susceptibility gene; GHS=global health status; HER2-=human epidermal growth factor receptor 2 negative; HR+=hormone receptor-positive; LA/mBC=locally advanced/metastatic breast cancer; PARP=poly (ADP-ribose) polymerase; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors; TNBC=triple-negative breast cancer.* Patients had a deleterious or suspected deleterious gBRCA mutation detected using a clinical trial assay.1† Capecitabine, eribulin, gemcitabine, or vinorelbine.​​​​​​​ Explore more Baseline characteristics
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. Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377(6):523-533. Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation (supplementary appendix). N Engl J Med. 2018;379(8):753-763. Data on file. Pfizer Inc., New York, NY.
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.
​​​​​​​ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of full SmPC for how to report adverse reactions.

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0059 April 2023
About Significantly longer PFS 

Superior to chemotherapy in delaying disease progression1

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Improved patient-reported outcomes

Significant improvements in GHS/QoL and breast symptoms6​​​​​​​

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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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