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For TALZENNA® (talazoparib) Prescribing Information click here.
TALZENNA® + enzalutamide achieved a median OS > 3.8 years in TALAPRO-2 — the longest reported in mCRPC trials to date.1
Example
Figure adapted from Agarwal, N et al. 2025.1
Data cutoff 3 Sept 2024 OS analysis corresponds to median duration of follow-up of 52.5 months for the talazoparib + enzalutamide arm and 53.0 months for placebo + enzalutamide.
In patients without HRR gene alterations, overall survival benefit was maintained with TALZENNA® + enzalutamide vs enzalutamide + placebo.1
Figure adapted from Agarwal, N et al. 2025.1
Data cutoff 3 Sept 2024 for this post-hoc OS analysis corresponds to median duration of follow-up of 52.5 months for the talazoparib + enzalutamide arm and 53.0 months for placebo + enzalutamide.1
Overall Survival in Subgroups with No Alterations Detected by Both ctDNA and Tumour Tissue.1
Post-hoc analysis. For Descriptive Purpose Only.
rPFS Data (primary endpoint): Talazoparib + enzalutamide significantly increased median rPFS vs enzalutamide + placebo in patients with or without HRR gene alterations.1, 2, a
Figure adapted from TALZENNA® Summary of Product Characteristics.2
Data cutoff was the 16th August 2022. Median follow-up for rPFS was 24.9 months (IQR 21.9-30.2) for the TALZENNA® group and 24.6 months (IQR 14.4-30.2) for the placebo group.1
More than 2.5 years median rPFS reached regardless of HRRm status in extended follow-up.1
Figure adapted from Agarwal, N et al. 2025.1
This updated rPFS is for descriptive purposes only as the primary endpoint was met in the prior analysis.
Data cutoff 3 Sept 2024 BICR rPFS analysis corresponds to median duration of follow-up of 47.0 months for the talazoparib + enzalutamide arm and 46.9 months for placebo + enzalutamide.
TALZENNA® + enzalutamide: Achieved Consistent Improvement in Median rPFS Across Patient Subgroups.2
Consistent with the overall results, a reduction in the risk of radiographic progression or death in favour of TALZENNA® + enzalutamide was achieved across all patient subgroups, including patients with or without HRR gene alterations and patients with or without prior treatment with abiraterone and/or a taxane.2
Example
Figure adapted from TALZENNA® Summary of Product Characteristics for United Kingdom.2
* All patients on a Taxane received Docetaxal.1, 2
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.1, 3
rPFS was the primary endpoint of the TALAPRO-2 Study.1, 2
Figure adapted from Agarwal N et al. 2023.3
Data cutoff 16 Aug 2022 for this BICR ORR analysis corresponds to median follow-up of 24·9 months for the talazoparib + enzalutamide group and 24·6 months for the placebo + enzalutamide group.
* ORR was defined as the proportion of patients with measurable soft-tissue disease at baseline who had a best overall confirmed soft-tissue response of complete response or partial response according to RECIST 1.1.3
ORRs were assessed at the time of the primary PFS analysis. ORR was a prespecified analysis assessed by BICR using RECIST 1.3 1, but did not evaluate statistical significance; therefore, the ORR results are descriptive in nature only.3
arPFS was defined as the time from the date of randomisation to first objective evidence of radiographic progression by blinded independent review or death (occuring within 168 days of treatment discontinuation), whichever occured first. rPFS also evaluated according to RECIST 1.1 and PCWG3 (bone) criteria.3
bAll patients received androgen deprivation therapy concurrently or had bilateral orchiectomy.3
Abbreviations:
1L - First Line, ADT- Androgen Deprivation Therapy, AR - Androgen Receptor, ARPi - Androgen Receptor Pathway Inhibitor, BICR - Blinded Independent Central Review, CI - Confidence Interval, CR - Complete Response, HR - Hazard Ratio, HRR - Homologous Recombination Repair, HRRm - Homologous Recombination Repair Gene-Mutated, ITT - intent-to-treat, LNRH - Luteinising hormone-releasing hormone, mCRPC - Metastatic Castration-Resistant Prostate Cancer, NHT - Novel Hormonal Therapy, NR - Not Reached, ORR - Objective Response Rate, OS - Overall Survival, PARPi - Poly ADP-ribose Polymerase Inhibitor, PSA - Prostate-Specific Antigen, RECIST - Response Evaluation Criteria in Solid Tumours, RP - Radiographic Progression, rPFS - Radiographic Progression-Free Survival, SE - Study Entry, SM - Site of Metastasis, w/o - Without
1. Agarwal N, Azad AA, Carles J, et al. Final overall survival (OS) with talazoparib (TALA) + enzalutamide (ENZA) as first-line treatment in unselected patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 TALAPRO-2 trial. Oral Slides Presented at ASCO GU Annual Meeting, 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; 402(10398):291-303. [Accessed: May 2025].
PP-TXT-GBR-0037 May 2025
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