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

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TALZENNA MoA

Talzenna MoA

gBRCA testing

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Guidelines

Study design

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Efficacy & Safety

TALZENNA efficacy

Primary endpoint & subgroup analysis

Secondary endpoints: ORR

Secondary endpoint: OS

Exploratory endpoints: DoR & TTR

TALZENNA safety

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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 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

See the data

Manageable safety profile

AEs were manageable with a low discontinuation rate⁵

Review Safety

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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PP-UNP-IRL-0784. June 2024

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PP-UNP-IRL-0784. June 2024