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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

2294 - TALAPRO-1: An open-label, response rate phase 2 study of talazoparib (TALA) in men with DNA damage repair defects (DDR) and metastatic castration-resistant prostate cancer (mCRPC) who previously received taxane-based chemotherapy (CT) and progressed on _1 novel hormonal therapy (NHT)


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Cytotoxic Therapy

Tumour Site

Prostate Cancer


Johann de Bono


Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284


J.S. de Bono1, C. Higano2, F. Saad3, K. Miller4, M. Casey5, A. Czibere6, C. Healy5, K. Fizazi7

Author affiliations

  • 1 Drug Development Unit, The Royal Marsden NHS Foundation Trust, SW7 3RP - London/GB
  • 2 Medical Oncology, Fred Hutchinson Cancer Research Center, Seattle/US
  • 3 Urology, Centre Hospitalier de l’Universite de Montréal (CHUM), H2X 0A9 - Montreal/CA
  • 4 Medical Oncology, Charité–Universitätsmedizin Berlin, Berlin/DE
  • 5 Medical Oncology, Pfizer, Inc., Collegeville/US
  • 6 Medical Oncology, Pfizer, Inc., Cambridge/US
  • 7 Cancer Medicine, Institut Gustave Roussy, 94800 - Villejuif/FR

Abstract 2294


No therapies are currently approved for men with mCRPC who have progressed on taxane and NHT. Preclinical evidence has shown that DDR+ prostate tumours may be sensitized to PARP inhibition. TALA inhibits PARP activity and traps PARP on DNA, preventing DNA damage repair and causing cell death in BRCA1/2-mutated cells.

Trial design

Approximately 100 patients (pts) will be enrolled. Eligible pts are ≥18 yrs with measurable soft tissue disease per RECIST v1.1 and have progressive mCRPC, DDR likely to sensitize to PARP inhibition, ECOG PS ≤ 2, no brain metastases, and received 1-2 CT regimens (including ≥1 taxane-based regimen) and progressed on ≥ 1 NHT (enzalutamide or abiraterone acetate). Pts who received a prior PARP inhibitor, cyclophosphamide, mitoxantrone, or a platinum-based CT within 6 mos of study entry or progressed on a platinum-based CT at any time are excluded. Pts will receive TALA 1 mg/d orally (or 0.75 mg/d for those with moderate renal impairment) until radiographic progression, unacceptable toxicity, or withdrawal of consent. Study drug should not be discontinued based on increased PSA or circulating tumour cell (CTC) count alone. Primary endpoint is best objective response (OR) rate (exact 2-sided 95% CI), defined as a complete or partial soft tissue response per RECIST v1.1. Responses must be confirmed ≥4 wks later by CT/MRI with no evidence of confirmed bone progression per PCWG3 criteria on repeat bone scan ≥6 wks later. Secondary endpoints include time to OR, duration of response, PSA decrease ≥50%, CTC count conversion (to CTC=0 and CTC <5 per 7.5 mL of blood), time to PSA progression, radiographic progression-free survival, overall survival, safety, patient-reported outcomes, and pharmacokinetics of TALA. Efficacy will be assessed every 8 wks during the first 24 wks, then every 12 wks thereafter. An initial safety and efficacy analysis will be performed on 20 pts after receiving study drug ≥8 wks. An interim efficacy analysis is planned when 60 pts have completed ≥6 mos of treatment.

Clinical trial identification


Legal entity responsible for the study

Pfizer, Inc.


This study was sponsored by Pfizer Inc.

Editorial Acknowledgement

Editorial and medical writing support funded by Pfizer Inc. were provided by Edwin Thrower, PhD, Mary Kacillas and Paula Stuckart of Ashfield Healthcare Communications, Middletown, Connecticut.


J.S. de Bono: Consulting fees: AstraZeneca, Sanofi, Genentech, Astellas, Bayer, Pfizer, Merck Sharp & Dohme, Merck Serono, Boehringer Ingelheim; Honoraria: AstraZeneca, Sanofi, Astellas, Pfizer, Genentech; Contracted research: AstraZeneca, Genentech, Sanofi. C. Higano: Consulting fees: Dendreon, Bayer, Ferring, Orion Corp, Astellas, Clovis, Asana Biosciences, Endocyte, Blue Earth Diagnostics, Myriad Genetics, Tolmar; Honoraria: Genentech; Contracted research Aragon, AstraZeneca, Dendreon, Genentech, Medivation, Emergent BioSolutions, Bayer, Pfizer, Roche, Astellas. F. Saad: Consulting fees: Astellas, Janssen, Amgen, Sanofi, AstraZeneca; Honoraria: Astellas, Abbvie, Amgen, Janssen, Sanofi, Bayer; Contracted research: Astellas, Bayer, Amgen, Janssen, BMS, Oncogenex, Sanofi. K. Miller: Consulting fees, Honoraria: Advanced Accelerator Applications, Amgen, Bayer, BMS, Ferring, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sotio, Tolmar. M. Casey, A. Czibere, C. Healy: Employee: Pfizer, Inc. K. Fizazi: Consulting fees, honoraria: Astellas.

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