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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
In the final overall survival (OS) analysis, statistical significance  was not met1

  • Subsequent treatments may have confounded survival outcomes: most patients received subsequent therapies (80.8% in TALZENNA arm, 76.4% in chemotherapy* arm); 59.7% in chemotherapy arm and 48.4% in TALZENNA arm received subsequent treatment with PARPi and/or platinum

Adapted from Litton et al. Ann Oncol. 2020.1OS adjusted for subsequent platinum and/or PARPi use1†‡§||   Adjusting for post-study PARP inhibition and/or platinum therapy reduced the HR and lowered the upper bound of the 95% Cl but did not reach statistical significance. Adapted from Litton et al. Ann Oncol. 2020.1
AEs=adverse events; Cl=confidence interval; DoR=duration of response; GHS=global health status; HR=hazard ratio; NS=not significant; ORR=objective response rate; PARP=poly (ADP-ribose) polymerase; PARPi=poly (ADP-ribose) polymerase inhibitor; QoL=quality of life; TTR=time to response.
Capecitabine, eribulin, gemcitabine, or vinorelbine. 
Statistical significance was not met when OS was adjusted for subsequent platinum and/or PARPi use. 
Most patients received subsequent therapies: 59.7% in the chemotherapy arm and 48.4% in the TALZENNA arm received subsequent treatment with a PARPi and/or platinum. 
Analysis using the rank-preserving structural failure time model (RPSFTM) method was performed. RPSFTM is a statistical method that was performed to estimate the treatment effect on OS adjusting for subsequent treatment with a PARPi and/or platinum. These analyses give an estimate of the treatment effect on OS, as if patients in the chemotherapy arm had not taken a PARPi and/or platinum after discontinuation of chemotherapy. 
Conducted in the intent-to-treat population. Explore more Exploratory endpoints
References: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.TALZENNA Summary of Product Characteristics.
​​​​​​​▼ 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.
TALZENNA efficacy Improved patient-reported outcomes

Significant improvements in GHS/QoL and breast symptoms1

 See the results  Manageable safety profile

AEs were manageable with a low discontinuation rate2

 Review safety

Legal Category: S1A 
Further information is available upon request


PP-TAL-IRL-0071 September 2023

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