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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

2901 - A phase 2 study of INCB054828 as adjuvant therapy in patients (pts) with high-risk urothelial carcinoma (UC) harboring fibroblast growth factor receptor 3 (FGFR3) genomic alterations

Date

22 Oct 2018

Session

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

Topics

Tumour Site

Urothelial Cancers

Presenters

Andrea Necchi

Citation

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

Authors

A. Necchi1, J.L. Pérez-Gracia2, Y. Loriot3, W. Witjes4, F. Montorsi5, A. Bjartell6, S.F. Shariat7

Author affiliations

  • 1 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 2 Medical Oncology, Clínica Universitaria de Navarra, 35006 - Pamplona/ES
  • 3 Department Of Cancer Medicine, Institut Gustave Roussy, 94800 - Villejuif/FR
  • 4 Research Foundation, European Association of Urology, 6803 - Arnhem/NL
  • 5 Urological Research Institute (uri), IRCCS San Raffaele, 20132 - Milan/IT
  • 6 Urology, Skåne University Hospital Malmö, Malmö/SE
  • 7 Urology, Medical University of Vienna, Vienna/AT
More

Resources

Abstract 2901

Background

After neoadjuvant chemotherapy (NAC), about 20% of pts with muscle-invasive UC are found to have advanced pT-stage or lymph node involvement and 5-year overall survival (OS) of them is < 30%. Tumor samples from these pts may provide information about chemotherapy resistance, and may predict for the activity of new drugs given postoperatively. Alterations of FGFR3 gene represent a therapeutic target in UC and FGFR3 mutations/fusions are enriched in UC Luminal-1 subtype. The pan-FGFR inhibitor INCB054828 has shown promising results in chemotherapy-treated patients with genomic alterations of FGFR3 in tumor tissue and is currently being evaluated in an international phase 2 study (fight-201, NCT02872714). Our study aims to assess the safety and efficacy of adjuvant INCB054828 in pts with FGFR3 mutations/fusions.

Trial design

This is an open-label, single-arm, phase 2 study. Subjects will receive INCB054828 at a once-daily (QD) dose of 13.5 mg on a 2-weeks-on and 1-week-off schedule. Treatment should start within 60 days of surgery and will continue until 12 months, or until the evidence of disease recurrence or unacceptable toxicity onset. Key inclusion criteria are predominant UC histology, FGFR3 mutations/fusions (FoundationOne), bladder or upper tract UC, previous radical cystectomy or nephroureterectomy, previous administration ≥3 cycles of CDDP-based NAC, pT3-4 and/or pN1-3 stage. Relapse-free survival (RFS) is the primary endpoint, assessed every 9 weeks until disease recurrence or death. No interim analyses are planned. It is expected that about 30% of the total screened pts will harbor FGFR3 aberrations. In a single-stage design, with 90% power and one-sided alpha at 0.10, the total enrolled pts will be 56 (H0: 2-y RFS: 30%; H1: 2-y RFS: 45%). Translational research on tissue samples will include associations of immune-inflamed phenotype with next-generation sequencing results and outcome of treatment, and response to any subsequent immunotherapy. The study is sponsored by the EAU-Research Foundation and will involve 15 centers in Europe (EudraCT number 2017-004426-15).

Clinical trial identification

EudraCT: 2017-004426-15.

Legal entity responsible for the study

European Association of Urology Research Foundation.

Funding

Incyte Inc.

Editorial Acknowledgement

Disclosure

A. Necchi: Consultant role for Incyte Inc. W. Witjes: Employee of EAU-RF. All other authors have declared no conflicts of interest.

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