This site is intended only for healthcare professionals resident in the Republic of Ireland

Search

Menu

Close

Sign in or RegisterLog out
Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up

Menu

Close

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
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

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

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit https://www.medicines.ie

 

This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.

 

Copyright © 2024 Pfizer Limited. All rights reserved.
 

PP-UNP-IRL-0733. March 2024
For Healthcare Professionals in the Republic of Ireland *

The information on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland and contains promotional content.

I confirm that I am a healthcare professional* resident in the Republic of Ireland.

If you select 'No', you will be redirected to Pfizer.ie, where you will be able to access information on Pfizer Healthcare Ireland.

*The IPHA Code definition of a healthcare profressional is a person of any of the following classes: (i) Registered medical practitioners (ii) Registered dentists (iii) Registered pharmacists (iv) Registered nurses

Terms of use

PP-UNP-IRL-0733 . March 2024

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.

PP-UNP-IRL-0733. March 2024