Real-World Characteristics and Treatment Patterns of Patients Treated with Talazoparib + Enzalutamide for Metastatic Castration- Resistant Prostate Cancer in the US Community Oncology Setting

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  TALZENNA

  XTANDI
• Study drug International non-proprietary name (INN) or common name:
  TALAZOPARIB

  ENZALUTAMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XK04) talazoparib

  talazoparib

  (L02BB04) enzalutamide

  enzalutamide

Population studied

• Short description of the study population:
  Patients with mCRPC who initiated talazoparib + enzalutamide within the US Oncology Network ("The Network") or Non-Network practices.

Study design details

• Study design:
  Retrospective observational cohort study of EHR data
• Main study objective:
  Primary objectives:; 1. To describe patient demographics and clinical characteristics.; 2. To describe the following HRRm testing patterns: ; a) The count and proportion of patients with documentation of HRRm testing overall and by timing of the first HRRm test relative to metastatic diagnosis and initiation of talazoparib + enzalutamide (i.e., prior to metastatic diagnosis, between metastatic diagnosis and initiation of talazoparib + enzalutamide); b) The count and proportion of patients undergoing subsequent HRRm testing prior to the end of the study observation period overall and by timing of HRRm test (sample size permitting) ; c) Time to the first documented HRRm testingfrom metastatic diagnosis and from initiation of talazoparib + enzalutamide; d) The distribution of HRRm test results among patients who received HRRm testing, including the count and proportion of patients with BRCA mutation(s),non-BRCA mutationsonly, or no mutations; e) The distribution of testing modality and assay type for the first documented HRRm test among patients who received HRRm testing; 3. To describe treatment patterns in the metastatic setting, including:; a) Line of therapy (LOT) of initiation of talazoparib + enzalutamide (as defined in Section 9.3.1); b) Distribution of treatment regimens received prior to initiation of talazoparib + enzalutamide, including regimens received in the mCSPC and mCRPC settings by LOT (if applicable); c) Distribution of regimens received following initiation of talazoparib + enzalutamide through the end of the follow-up period (as defined in Section 9.1); d) Starting dose and dose modifications of talazoparib + enzalutamide; e) Reasons for discontinuation of talazoparib + enzalutamide; ; Secondary objectives:; 1. To describe real-world clinical outcomes from initiation of talazoparib + enzalutamide, including:; a) Real-world time to treatment discontinuation (rwTTD); b) Real-world time to next treatment (rwTTNT); c) Real-world progression-free survival (rwPFS); d) Overall survival (OS); ; Exploratory Objectives:; 1. To describe the availability and distribution of prostate-specific antigen (PSA) and hemoglobin (Hgb) results after initiation of talazoparib + enzalutamide
• Setting:
  The US Oncology Network includes over 2,500 affiliated physicians operating in over 600 sites of care across states. Approximately 1.4 million US cancer patients are treated annually in The US Oncology Network. Non-Network practices are independent community-based oncology clinics that have a partnership with Ontada. Approximately 50 non-Network clinics have adopted the iKnowMed EHR and participate in real-world research activities with Ontada.