TALZENNA® (talazoparib)| About | Study Design | EMBRACA

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TALZENNA MoA

Talzenna MoA

gBRCA testing

Identifying patients

Guidelines

Study design

Baseline characteristics

Efficacy & Safety

TALZENNA efficacy

Primary endpoint & subgroup analysis

Secondary endpoints: ORR

Secondary endpoint: OS

Exploratory endpoints: DoR & TTR

TALZENNA safety

Safety and tolerabillity

Adverse events

Patient-reported outcomes with TALZENNA

Patient-reported outcomes

GHS/QoL

Breast symptoms

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Elevate

Personalising Breast Cancer Treatment

Understanding and Optimising PARP Inhibitors for mBC

PARP Inhibitors in mBC: the role of Real World Evidence

EMBRACA is the largest Phase 3, open-label study of PARP inhibitor monotherapy in gBRCA-mutated HER2- LA/mBC^1-3

Study design^1,2,4

Adapted from TALZENNA^® SmPC, and Litton et al., N Engl J Med 2018.²

Primary endpoint:^1,4

PFS defined as disease progression or death per RECIST v1.1, as assessed by BICR

Secondary endpoints included:^1,4

Objective response rate (ORR), as assessed by investigator
Overall survival (OS)
Safety

Exploratory endpoints included:^1,4

Duration of response (DoR) and time to response for objective responders
ORR subgroup analysis
Quality of life (QoL) assessed through patient-reported outcomes (PROs)

Broad range of patient types included in EMBRACA

EMBRACA included a broad range of prespecified patient populations, including TNBC, HR+/HER2- disease, age, with/without a history of CNS metastases, and visceral/nonvisceral disease²

Percentages shown are for the TALZENNA arm only.

Additional inclusion criteria:^1,5

Patients received 0, 1, 2, or 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, locally advanced and/or metastatic setting
Patients who had objective disease progression while receiving platinum chemotherapy for locally advanced or metastatic disease were excluded
Patients who received low-dose platinum therapy administered in combination with radiation therapy were not excluded
Patients who received platinum therapy in the adjuvant or neoadjuvant setting were eligible; however, patients may not have relapsed within 6 months of the last dose of prior platinum therapy
No prior treatment with a PARP inhibitor was permitted

BICR=blinded independent central review; CNS=central nervous system; gBRCA=germline breast susceptibility gene; GHS=global health status; HER2-=human epidermal growth factor receptor 2 negative; HR+=hormone receptor-positive; LA/mBC=locally advanced/metastatic breast cancer; PARP=poly (ADP-ribose) polymerase; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors; TNBC=triple-negative breast cancer.

* Patients had a deleterious or suspected deleterious gBRCA mutation detected using a clinical trial assay.¹

† Capecitabine, eribulin, gemcitabine, or vinorelbine.

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Baseline characteristics

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.

Robson M, Im S-A, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017;377(6):523-533.

Litton JK, Rugo HS, Ettl J, et al. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation (supplementary appendix). N Engl J Med. 2018;379(8):753-763.

Data on file. Pfizer Inc., New York, NY.

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.

Legal Category: S1A
Further information is available upon request

PP-TAL-IRL-0106 May 2024

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 symptoms⁶

See the data

TALZENNA Summary of Product Characteristics

Product Characteristics

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

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