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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 & ResourcesMaterials
Selected baseline characteristics1,2​​​​​​​
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TALZENNA (n=287) Chemotherapy* (n=144)
Demographics
Age, median (range), y 45 (27.0-84.0) 50 (24.0-88.0)
<50 y, No. (%) 182 (63.4) 67 (46.5)
50 y to <65 y, No. (%) 78 (27.2) 67 (46.5)
≥65 y, No. (%) 27 (9.4) 10 (6.9)
Female, No. (%) 283 (98.6) 141 (97.9)
Clinical status
Stage of BC

Locally advanced, No. (%) 15 (5.2) 9 (6.2)
Metastatic, No. (%) 271 (94.4) 135 (93.8)
ECOG PS 0/1/2, (%) 53.3/44.3/2.1 58.3/39.6/1.4
Measurable disease by investigator, No. (%) 219 (76.3) 114 (79.2)
History of CNS metastases, No. (%) 43 (15.0) 20 (13.9)
Visceral disease, No. (%) 200 (69.7) 103 (71.5)
Disease-free interval (initial diagnosis to ABC) <12 months, No. (%) 108 (37.6) 42 (29.2)
Hormone receptor status, No. (%)
TNBC 130 (45.3) 60 (41.7)
HR+/HER2- 157 (54.7) 84 (58.3)
BRCA status by central or local laboratory assessment, No. (%)†
BRCA1-mutation positive 133 (46.3) 63 (43.8)‡
BRCA2-mutation positive 154 (53.7) 81 (56.3)‡
Prior cytotoxic regimens for ABC, No. (%)
0 111 (38.7) 54 (37.5)
1 107 (37.3) 54 (37.5)
2 57 (19.9) 28 (19.4)
3 11 (3.8) 8 (5.6)
≥4 1 (0.3) 0 (0.0)
Number of patients who received following prior therapies, No. (%)
Taxane 262 (91.3) 130 (90.3)
Anthracycline 243 (84.7) 115 (79.9)
Platinum 46 (16.0) 30 (20.8)
Adapted from TALZENNA SmPC, and Litton et al. N Engl J Med. 2018.2
ABC=advanced breast cancer; BC=breast cancer; BRCA=breast cancer susceptibility gene; CNS=central nervous system; ECOG PS=Eastern Cooperative Oncology Group performance status; gBRCA=germline breast cancer susceptibility gene; GHS=global health status; HER2-=human epidermal growth factor receptor 2 negative; HR+=hormone receptor-positive; PFS=progression-free survival; QoL=quality of life; TNBC=triple-negative breast cancer.Capecitabine, eribulin, gemcitabine, or vinorelbine. Patients had a deleterious or suspected deleterious gBRCA mutation detected using a clinical trial assay.1Percentages do not add up to 100 due to rounding. Explore more Efficacy & safety
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. 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 

 See the data  Improved patient-reported outcomes

Significant improvements in GHS/QoL and breast symptoms3​​​​​​​

 See the results
TALZENNA Summary of Product Characteristics Product CharacteristicsLoading

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