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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
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.
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-0108 May 2024

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