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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: Safety Profile and Tolerability

Manageable safety and tolerability with TALZENNA® vs chemotherapy in patients with gBRCA-mutated advanced breast cancer. 1-3

The safety and tolerability of TALZENNA® in patients with gBRCA-mutated advanced breast cancer have been evaluated in the Phase 3 EMBRACA study. Of the 431 patients in the intention-to-treat population: 
  • 286 patients from the Phase 3, randomised EMBRACA study in patients with germline BRCA-mutated, HER2-negative, locally advanced or metastatic breast cancer.
  • 126 in the arm receiving physician’s choice chemotherapy* were available for safety profile analysis.1-3

Adverse events occuring in >20% in patients receiving TALZENNA® in the EMBRACA study 3,4
Haematological vs. Non-haematological AEs† Haematological AEs

The most common haematological AEs† observed with TALZENNA® in the EMBRACA study were anaemia, neutropenia and thrombocytopenia. Events occurred within the first 3-4 months and were transient. With appropriate management of Grades 3-4* anaemia‡, neutropenia§ and thrombocytopenia, median duration of event was 9 days or less.2,4,5 

Management included supportive medical therapy, including packed red blood cell transfusion (received by 38.1% of patients in the TALZENNA® arm). The median number of transfusions per patient was 2.2 

<2% of patients discontinued TALZENNA® due to haematologic events.2


Non-haematological AEs

The majority of non-haematological AEs in the TALZENNA® arm were grade 1 in severity. These included:1,3 
  • Fatigue (50.3% any event)
  • Nausea (48.6% any event)
  • Headache (32.5% any event)
  • Alopecia (25.2% any event)¶.

Adverse events associated with Talzenna® were managed with standard support of medical therapy or dose reduction/interuption6,7† Dose reductions
 
  • Dose reductions due to any cause occured in 52.4% of TALZENNA® patients vs 35.7% of chemotherapy patients6,7
  • Median time to first dose reduction due to any adverse event was:6,7
           - 19.3 weeks (95% Cl: 17.1-30.9 months) with TALZENNA® vs.
           - 9.3 weeks (95% Cl: 6.4 months-NR) with chemotherapy**


Dose interruptions
  • Dose interruptions due to any adverse event of any grade occurred in 60.1% of TALZENNA® patients vs 32.7% of chemotherapy patients6,7


* Capecitabine, eribulin, gemcitabine, or vinorelbine in continuous 23-day cycles.1  
† Adverse event grades were evaluated with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. Patients with multiple adverse events were counted once for each preferred term, system organ class, and overall. Data on adverse events leading to permanent discontinuation of a trial drug were obtained from the adverse-event electronic case report form.1,4  
‡ Includes anaemia and decreased haemoglobin level.3  
§ Includes neutropenia, decreased neutrophil count, and neutropenic sepsis.3  
ll lncludes thrombocytopenia and decreased platelet count.3  
¶ Grade 1 defined as hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection. A different hairstyle may be required to cover the hair loss, but it does not require a wig or hairpiece to camouflage. Grade 2 defined as hair loss of ≥50% of normal for that individual that is readily apparent to others. A wig or hairpiece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact.4
** Capecitabine was the only oral chemotherapy included in the comparator arm.6,7
AE=adverse event; CI=confidence interval; NR=not reported; PFS=progression-free survival.
References: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.Hurvitz SA, Gonҫalves A, Rugo HS, et al. Talazoparib in patients with a germline BRCA-mutated advanced breast cancer: detailed safety analyses from the phase III EMBRACA trial. Oncologist. 2019;24:1-12.Litton JK, et al. N Engl J Med. 2018;379(8):753-763. Supplementary MaterialNational Institutes of Health, US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE). Bethesda, MD: National Institutes of Health. Revised June 2010, version 4.03. NIH publication 09-5410Ettl J, et al. Ann Oncol. 2018;29:1939-1947Data on file. Pfizer Inc., New York, NY Hurvitz SA, et al. Oncologist. 2019;24:1-27. Supplementary Material

Legal Category: S1A 
Further information is available upon request

PP-TAL-IRL-0107 May 2024
TALZENNA® safety Significantly longer PFS

Superior to chemotherapy in delaying disease progression6

 See the data  Convenient, once-daily oral dosing

One dose once a day with or without food6​​​​​​​

 Learn more
TALZENNA Summary of Product Characteristics Product CharacteristicsLoading

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Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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