EMBRACA: Efficacy Outcomes | TALZENNA®▼ (talazoparib)

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The content of this website has been produced in line with the Talzenna®▼ Summary of Product Characteristics for Great Britain and Northern Ireland. Talzenna® (talazoparib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.

EMBRACA Study: Efficacy Outcomes

Study Design

The EMBRACA study is a Phase III, open-label study evaluating the efficacy and safety of PARP inhibitor monotherapy, TALZENNA^®, vs. chemotherapy in patients with gBRCA1/2-mutated HER2- locally advanced or metastatic breast cancer.^*†1-4

* Patients had a deleterious or suspected deleterious gBRCA mutation detected using a clinical trial assay.²
† Physician's choice chemotherapy included capecitabine (44% of treatment arm), eribulin (40%), gemcitabine (10%) or vinorelbine (7%); percentages total >100% due to rounding.²
‡ PFS was determined by BICR and defined as the time from randomisation to the date of first documented radiologic progression according to RECIST v1.1 or the date of death from any cause, whichever occurred first.²
§ ORR defined as the proportion of patients in the tumour-evaluable population with measurable disease at baseline who experienced complete or partial response.⁴
¶ OS defined as the time from randomisation to death from any cause.⁴
** DoR was defined as the time from the first radiographic documentation of objective response to disease progression by investigator assessment using RECIST v1.1 or death due to any cause, whichever occurred first.³

Key inclusion criteria:^1-4

Patients had received 0, 1, 2 or 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
Patients had received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, locally advanced and/or metastatic setting
Patients had received low-dose platinum therapy administered in combination with radiation therapy
Patients had received platinum therapy in the adjuvant or neoadjuvant setting
No prior treatment with a PARP inhibitor

Key exclusion criteria:^1-4

Patients had objective disease progression while receiving platinum chemotherapy for locally advanced or metastatic disease were excluded
Patients had relapsed within 6 months of the last dose of prior platinum therapy

EMBRACA included a broad range of patient populations^1-3,5

Table adapted from Litton JK, et al. 2018

Key Study Results

Median PFS was significantly prolonged with TALZENNA^® versus chemotherapy (primary endpoint, ITT population)^1,2

Median PFS was 8.6 months with TALZENNA^® compared to 5.6 months with chemotherapy (hazard ratio=0.54; p<0.0001).^1,2

At 1 year, 37% of TALZENNA® patients (n=106) did not have disease progression at 1 year compared to 20% of chemotherapy patients (n=29).²

Data cut-off: 15 September 2017. Median duration of follow-up for PFS was 11.2 months.
Adapted from Litton JK, et al. 2018.

PFS results observed across prespecified subgroups defined by baseline variables^‡#1-4

Small patient numbers can be a limitation of subgroup analyses. These analyses may not be powered to detect significant differences and were not designed to compare across subgroups. Any comparison between groups should be interpreted with caution.

Example

Adapted from Rugo HS, et al. 2020.
Data cut-off: 15 September 2017. Median duration of follow-up for PFS was 11.2 months.
# Depicts subgroup analyses from the overall EMBRACA ITT study population: TALZENNA® arm (n=287), chemotherapy arm (n=144). Prespecified subgroup analyses of PFS by baseline variables were conducted to assess the consistency of treatment effects across subgroups.^1-4

PFS in subgroups of patients with gBRCA-mutated HER2- LA/mBC receiving TALZENNA^® versus chemotherapy^#4

Adapted from Rugo HS, et al. 2020.⁴
Data cut-off: 15 September 2017. Median duration of follow-up for PFS was 11.2 months.
# Depicts subgroup analyses from the overall EMBRACA ITT study population: TALZENNA® arm (n=287), chemotherapy arm (n=144). Prespecified subgroup analyses of PFS by baseline variables were conducted to assess the consistency of treatment effects across subgroups.^1-4

In the final OS analysis, statistical significance was not met⁵

The EMBRACA trial did not meet the secondary endpoint of OS⁵

Adapted from Litton JK, et al. 2020.
Data cut-off: 30 September 2019. Median follow-up of 44.9 months (95% CI: 37.9-47.0) and 36.8 (95% CI: 34.3-43.0) in the TALZENNA^® group versus the chemotherapy group, respectively.

Type of Adverse Reactions	Adverse Reactions	Withhold TALZENNA Until Levels Resolve to	Resume TALZENNA
Hematologic	Hemoglobin <8 g/dL	≥9 g/dL	Resume TALZENNA at a reduced dose
	Platelet count <50,000/μL	≥75,000/μL
	Neutrophil count <1,000/μL	≥1,500/μL
Nonhematologic	Grade 3 or Grade 4	≤ Grade 1	Consider resuming TALZENNA at a reduced dose or discontinue

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EMBRACA Study: Patient-Reported Outcomes (PROs)

View the Patient-Reported Outcomes (PROs) page

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EMBRACA Study: Safety and Tolerability

View the Safety and Tolerability page

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ABC: advanced breast cancer, BICR: blinded-indepdent central review, BRCA: breast cancer susceptibility gene, CI: confidence interval, CNS: central nervous system, DoR: duration of response, ECOG: Eastern Cooperative Oncology Group, EORTC: European Organisation for Research and Treatment of Cancer gBRCA: germline breast cancer susceptibility gene HER2: human epidermal growth factor receptor 2, HR: hormone receptor, HR+: hormone receptor-positive, ITT: intention-to-treat, LA: locally advanced, mBC: metastatic breast cancer, NS: not significant, ORR: objective response rate, OS: overall survival, PFS: progression-free survival, PRO: patient-reported outcome, QLQ-BR23: Quality of Life Questionnaire-Breast Cancer Module, QLQ-C30: Quality of Life Questionnaire-Core 30, QoL: quality of life; RECIST: Response Evaluation Criteria in Solid Tumours, TNBC: triple-negative breast cancer

References:

TALZENNA® Summary of Product Characteristics for Great Britain click here. TALZENNA® Summary of Product Characteristics for Northern Ireland click here.

Litton JK, et al. N Engl J Med. 2018;379(8):753-763.

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

Rugo HS, et al. JNCI Cancer Spectr. 2020;4(1):1-12.

Litton JK, et al. Ann Oncol. 2020;31(11):1526-1535.

PP-TAL-GBR-0211. July 2024

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