TALZENNA® (talazoparib)| Efficacy and safety | Patient reported outcomes with TALZENNA

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TALZENNA MoA

Talzenna MoA

gBRCA testing

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TALZENNA efficacy

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Secondary endpoint: OS

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Patient-reported outcomes with TALZENNA

Patient-reported outcomes

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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 Study Patient-reported outcomes (PROs) were assessed using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires¹

PROs were included as exploratory endpoints in an open-label study; analyses were prespecified and adjustments for multiplicity were not made. No efficacy conclusions can be made from these data²

EORTC QLQ-C30 and EORTC QLQ-BR23 have established reference values in the metastatic setting, showing their validity and reliability for quality of life (QoL) assessment in patients with LA/mBC³

EORTC QLQ-C30 is a general cancer-related PRO instrument^1,3,4

Assesses PROs in the following scales validated individually, not collectively:

Global health status/quality of life (GHS/QoL)
Functional status across 5 scales: physical, role, emotional, cognitive, and social functioning
Symptom severity across 8 scales: fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea

EORTC QLQ-BR23 is a breast cancer-specific PRO instrument^1,3

Assesses PROs in the following scales validated individually, not collectively:

Functional status across 4 scales: body image, sexual functioning, sexual enjoyment, and future perspective
Symptom severity across 4 scales: side effects, breast symptoms, arm symptoms, and upset by hair loss

Scoring^1,3

GHS/QoL is evaluated using two 7-point Likert scales with responses from "very poor" to "excellent." A 4-point Likert scale with responses from "not at all" to "very much" is used to evaluate functional and symptom scales.

AE=adverse event; EORTC=European Organisation for Research and Treatment of Cancer; LA/mBC=locally advanced/metastatic breast cancer; PFS=progression-free survival; QLQ-BR23=Quality of Life Questionnaire–Breast Cancer Module; QLQ-C30=Quality of Life Questionnaire–Core 30.

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GHS/QoL

References:

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.

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.

Fayers PM, Aaronson NK, Bjordal K, et al; on behalf of the EORTC Quality of Life Group. The EORTC QLC-C30 Scoring Manual. 3rd ed. Brussels, Belgium: European Organisation for Research and Treatment of Cancer; 2001.

Ettl J, Quek RGW, Lee KH, et al. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018;29:1939-1947.

TALZENNA® Summary of Product Characteristics.

Legal Category: S1A
Further information is available upon request

PP-TAL-IRL-0107 May 2024

Patient-reported outcomes with TALZENNA®

Significantly longer PFS

Superior to chemotherapy in delaying disease progression⁵

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Manageable safety profile

AEs were manageable with a low discontinuation rate⁵

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TALZENNA Summary of Product Characteristics

Product Characteristics

Adverse events should be reported.

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or email Pfizer at [email protected] or visit www.PfizerMedicalInformation.ie

Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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PP-UNP-IRL-0891. February 2025

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PP-UNP-IRL-0891. February 2025