PROfound: Phase III study of olaparib versus enzalutamide or abiraterone for metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene alterations

SK Sandhu; M Hussain; J Mateo; K Fizazi; F Saad; N Shore; K Chi; O Sartor; N Agarwal; D Olmos; A Thiery-Vuillemin; P Twardowski; N Mehra; C Goessl; J Kang; J Burgents; W Wu; A Kohlmann; C Adelman; J de Bono

Conference Proceedings

PROfound: Phase III study of olaparib versus enzalutamide or abiraterone for metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene alterations

SK Sandhu, M Hussain, J Mateo, K Fizazi, F Saad, N Shore, K Chi, O Sartor, N Agarwal, D Olmos, A Thiery-Vuillemin, P Twardowski, N Mehra, C Goessl, J Kang, J Burgents, W Wu, A Kohlmann, C Adelman, J de Bono

ANNALS OF ONCOLOGY | OXFORD UNIV PRESS | Published : 2019

DOI: 10.1093/annonc/mdz446.007

Abstract

Background Loss-of-function alterations in HRR genes are associated with response to PARP inhibition. PROfound (NCT02987543) is a randomized, open-label, Phase III trial evaluating efficacy and safety of olaparib (ola) vs enzalutamide (enza) or abiraterone (abi) in patients (pts) with mCRPC with alterations in any of 15 predefined genes with a direct or indirect role in HRR whose disease had progressed on prior new hormonal agent (NHA) therapy. Methods Qualifying tumor tissue HRR alterations were centrally and prospectively identified using an investigational next-generation sequencing test (Foundation Medicine, Inc). Cohort A included pts with alterations in BRCA1, BRCA2 or ATM; Cohort B pt..

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