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For TALZENNA® (talazoparib) Prescribing Information click here.
The content of this website has been produced in line with the Talzenna Summary of Product Characteristics for the United Kingdom. Talzenna (talazoparib) Prescribing Information for The United Kingdom click here. Adverse event reporting information can be found at the bottom of the page.
The objective of TALAPRO-2 was to assess the safety and efficacy of talazoparib + enzalutamide vs. enzalutamide + placebo as 1st line treatment in patients with mCRPC.1
Patients were enrolled from 223 hospitals, cancer centres, and medical centres in 26 countries.1
Patients were prospectively assessed for HRR gene alterations in tumour tissue and randomly assigned (1:1) to talazoparib 0.5 mg or placebo, plus enzalutamide 160 mg, administered orally once daily.1
Figure adapted from Agarwal N. et al. 2023.3
rPFS was defined as time from the date of randomisation to first objective evidence of radiographic progression by blinded independent review, or death (occurring within 168 days of treatment discontinuation), whichever occurs first.3
To maintain overall type I error, alpha was split equally between the all-comers cohort and the ongoing HRR selected population. A one-sided test was used to show superiority of the active treatment (talazoparib over placebo). The overall one-sided alpha for the study was controlled at 0·025, which was equivalent to two-sided 0·05.3
All patients kept receiving ongoing ADT, unless the patient received prior bilateral orchiectomy.3
*Serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening.3
†Documented by bone scan or CT/MRI of the soft tissue.3
‡Defined as PSA progression, soft tissue disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. and/or bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3).3
§Two patients received prior orteronel.3
¶rPFS also evaluated according to RECIST 1.1 and PCWG3 (bone) criteria.3
Figure adapted from Agarwal N, et al. 2023.1, 3
*corresponding figures for the placebo + enzalutamide treatment arm were also 79% (319/403) and 21% (84/403).
Abbreviations:
1L - First Line, ADT - Androgen Deprivation Therapy, AML - Acute Myeloid Leukaemia, AR - Androgen Receptor, BICR - Blinded Independent Central Review, CRPC - Castration-Resistant Prostate Cancer, CSPC - Castration-Sensitive Prostate Cancer, CVD - Cardiovascular Disease, ECOG - Eastern Cooperative Oncology Group, ECOG PS - Eastern Cooperative Oncology Group Performance Status, HRR - Homologous Recombination Repair, mCRPC - Metastatic Castration-Resistant Prostate Cancer, MDS - Myelodysplastic Syndrome, NHT - Novel Hormonal Therapy, ORR - Objective Response Rate, OS - Overall Survival, PARPi - Poly ADP-ribose Polymerase Inhibitor, PSA - Prostate-Specific Antigen, PCWG3 - Prostate Cancer Working Group 3, RECIST - Response Evaluation Criteria in Solid Tumours, rPFS - Radiographic Progression-Free Survival
1. Agarwal N, Azad AA, Carles J, et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet 2023;402(10398):291-303. [Accessed: May 2025].
2. TALZENNA® (talazoparib) Summary of Product Characteristics for United Kingdom. Available on www.medicines.org.uk
3. Agarwal N, Azad AA, Carles J, et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet 2023; Supplementary Appendix. [Accessed: May 2025].
PP-TXT-GBR-0034 May 2025
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