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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

4488 - ATLAS: a phase 2, open-label study of rucaparib in patients (pts) with locally advanced (unresectable) or metastatic urothelial carcinoma


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


Tumour Site

Urothelial Cancer


Simon Chowdhury


Annals of Oncology (2018) 29 (suppl_8): viii303-viii331. 10.1093/annonc/mdy283


S. Chowdhury1, S. Feyerabend2, Y. Loriot3, A. Necchi4, S. Gupta5, D.H. Josephs6, A. Rodríguez-Vida7, S. Srinivas8, Y. Zakharia9, D. Nepert10, K. Wride11, D. Thomas12, A. Loehr13, A.D. Simmons14, P. Grivas15

Author affiliations

  • 1 Medical Oncology, Guy's Hospital and Sarah Cannon Research Institute, SE1 9RT - London/GB
  • 2 Urologic Oncology, Studienpraxis Urologie, Nürtingen/DE
  • 3 Department Of Cancer Medicine, Gustave Roussy Cancer Campus, 94800 - Villejuif/FR
  • 4 Department Of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 5 Genitourinary Oncology Program, Huntsman Cancer Institute, University of Utah, Salt Lake City/US
  • 6 Department Of Medical Oncology, Guy's and St. Thomas' Hospital, SE1 9RT - London/GB
  • 7 Genitourinary Cancer Unit, Hospital del Mar, 28023 - Barcelona/ES
  • 8 Urologic Oncology Clinic, Stanford University School of Medicine, 94305 - Stanford/US
  • 9 Division Of Hematology, University of Iowa and Holden Comprehensive Cancer Center, 52242 - Iowa City/US
  • 10 Clinical Science, Clovis Oncology, Inc., 80301 - Boulder/US
  • 11 Biostatistics, Clovis Oncology, Inc., 80301 - Boulder/US
  • 12 Clinical Operations, Clovis Oncology, Inc., 80301 - Boulder/US
  • 13 Translational Medicine, Clovis Oncology, Inc., 80301 - Boulder/US
  • 14 Translational Medicine, Clovis Oncology, Inc., 94158 - Boulder/US
  • 15 Dept. Of Medicine, Division Of Oncology, University of Washington, 44195 - Seattle/US

Abstract 4488


There are currently no standard treatment options for pts with metastatic urothelial carcinoma (mUC) who have progressed on or after platinum (cisplatin/carboplatin)–based chemotherapy (PBC) and/or immune checkpoint inhibitors (ICIs). Analysis of The Cancer Genome Atlas bladder cancer dataset suggests that approximately 60% of bladder tumours have homologous recombination deficiency (HRD), as identified by a deleterious mutation in a homologous recombination pathway gene or high genomic loss of heterozygosity (LOH). Poly(ADP-ribose) polymerase (PARP) inhibitors have demonstrated clinical activity and are approved in other indications for tumours with HRD. We hypothesise that PARP inhibition has antitumour activity in mUC. The ATLAS (NCT03397394) trial is evaluating the efficacy and safety of the PARP inhibitor rucaparib as monotherapy treatment for pts with locally advanced (unresectable) or metastatic UC previously treated with PBC and/or ICI.

Trial design

Eligible pts must have received 1–2 prior standard-of-care treatments (eg, PBC and/or ICI) and have radiographic progression, measurable disease (RECIST v1.1) and adequate organ function. Confirmation of HRD status before enrolment is not required; however, fresh tumour or recently obtained archival tissue is mandatory for central HRD profiling. Prior PARP inhibitor treatment is exclusionary. All pts will receive rucaparib monotherapy (600 mg BID) until disease progression or other reason for discontinuation. The coprimary endpoints are confirmed objective response rate (investigator-assessed per RECIST v1.1) in the HRD-positive (signature based on tumour genomic LOH) and intent-to-treat populations. Secondary endpoints include response duration, progression-free survival, overall survival, safety and pharmacokinetics. Exploratory endpoints include evaluation of molecular biomarkers associated with response and resistance to rucaparib, including changes in plasma and tumour samples. Pts are being enrolled in 6 countries (target, N = 200). The study has >90% power to reject the null hypothesis (P = 0.10) at a 5% significance level if the true response rate for rucaparib is 20%.

Clinical trial identification


Legal entity responsible for the study

Clovis Oncology, Inc.


Clovis Oncology, Inc.

Editorial Acknowledgement

Writing and editorial support, funded by Clovis Oncology, Inc. (Boulder, CO, USA) was provided by Ritu Pathak, PhD, and Shannon Davis of Ashfield Healthcare Communications (Middletown, CT, USA).


S. Chowdhury: Consulting or advisory role and/or on speakers bureaus: Clovis Oncology, Sanofi, Pfizer, Astellas Pharma, Janssen; Honoraria: GlaxoSmithKline, Novartis; Research funding: Sanofi, Johnson & Johnson. S. Feyerabend: Advisory boards: Janssen, Boehringer Ingelheim Pharma, Aventis; Honorarium: Janssen; Travel and accommodation expenses: Aventis. Y. Loriot: Consulting or advisory role: Janssen, Astellas, Roche, MSD, Seattle Genetics, Pfizer, Bristol-Myers Squibb, AstraZeneca; Research funding: Sanofi, Johnson & Johnson, Merck Sharp & Dohme. S. Gupta: Research support for clinical trials: Pfizer, Five Prime Therapeutics, Hoosier Oncology Group, Rexahn Pharmaceuticals, Incyte, Bristol-Myers Squibb, Novartis, LSK BioPharma, Mirati, Merck; Spouse holds stock/equity in Salarius Pharmaceuticals. D.H. Josephs: Unbranded educational speaker program with Pfizer; Travel and accommodation expenses: EUSA Pharma, Ipsen. A. Rodríguez-Vida: Consulting or advisory role and/or on Speakers bureaus: Clovis Oncology, Merck Sharp & Dohme, Pfizer, BMS, Astellas, Janssen, Bayer, Roche; Honoraria: AstraZeneca, Sanofi Aventis; Research funding from Takeda, Pfizer, Merck Sharp & Dohme. Y. Zakharia: Advisory boards: Novartis, Amgen, Roche Diagnostics, Eisai, Exelixis, Castle Bioscience. D. Nepert, K. Wride, D. Thomas, A. Loehr, A.D. Simmons: Employee of Clovis Oncology and may own stock or have stock options in that company. P. Grivas: Consulting or advisory role with Clovis Oncology, Genentech, Bristol-Myers Squibb, Merck & Co, AstraZeneca, EMD Serono, Exelixis, Dendreon, Biocept, Seattle Genetics, Foundation Medicine, Driver Inc.; Unbranded educational speaker program (with direct input in slide content): Genentech, Bristol-Myers Squibb within the previous 2 years. All other authors have declared no conflicts of interest.

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