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Ongoing phase 2 study of erdafitinib (JNJ-42756493), a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in patients (pts) with metastatic or unresectable urothelial carcinoma (M/UR UC) and FGFR gene alterations

Date

09 Oct 2016

Session

Poster display

Presenters

Arlene Siefker-Radtke

Citation

Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373

Authors

A.O. Siefker-Radtke1, B. Mellado2, K. Decaestecker3, J.M. Burke4, A. O'Hagan5, A. Avadhani5, B. Zhong6, A. Santiago-Walker7, P. De Porre8, S. Brookman-May9, J. Garcia-Donas10

Author affiliations

  • 1 Genitourinary Medical Oncology, University of Texas, M.D. Anderson Cancer Center, 77030 - Houston/US
  • 2 Medical Oncology, Hospital Clinic de Barcelona, Barcelona/ES
  • 3 Urologie, Ghent University Hospital, Ghent/BE
  • 4 Medical Oncology, US Oncology Research and Rocky Mountain Cancer Centers, Aurora/US
  • 5 Clinical Oncology, Janssen Research & Development, Raritan/US
  • 6 Biostatistics, Janssen Research & Development, Raritan/US
  • 7 Translational Research And Biomarkers, Janssen Research & Development, Raritan/US
  • 8 Clinical Oncology, Janssen Research & Development, Beerse/BE
  • 9 Clinical Oncology, Janssen Research & Development and Ludwig-Maximilians-Universität München, Neuss/DE
  • 10 Gyn, Gu And Skin Cancer Unit, Centro Integral Oncólogico Clara Campal, Madrid/ES
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Resources

Abstract 1795

Background

European Society for Medical Oncology guidelines recommend cisplatin-based combination chemotherapy for M/UR UC; however, ~50% of pts cannot tolerate cisplatin. Following progression, the only European Medicines Agency-approved treatment is vinflunine, which offers modest survival improvement. FGFRs are involved in UC development, and ~10%-20% of pts with metastatic UC have FGFR alterations. In a phase 1 trial of pan-FGFR (FGFR1-4) inhibitor erdafitinib in pts with advanced solid tumors, promising antitumor activity and manageable safety profile were observed, including 3 partial responses among 8 pts with UC (Tabernero J, et al. J Clin Oncol. 2015;33:3401-3408). Efficacy and safety of 2 erdafitinib dose regimens are being evaluated in an open-label, phase 2 study in M/UR UC pts with specific FGFR translocations or mutations.

Trial design

Pts must have measurable (Response Evaluation Criteria In Solid Tumors v1.1) M/UR UC and either progression following chemotherapy or relapse within 12 months of last dose of neoadjuvant/adjuvant chemotherapy. They may have received any number of prior lines of treatment, including immunotherapy. Those who are chemotherapy naïve must be cisplatin ineligible per protocol. Eastern Cooperative Oncology Group performance status ≤ 2 and adequate bone marrow, liver, and kidney function (creatinine clearance ≥ 40 mL/min) are required. Pts are excluded if they have baseline phosphate persistently above the upper limit of normal or uncontrolled cardiovascular disease. Pts are randomized to an intermittent (10 mg/d, 7 d on/7 d off) or continuous (6 mg/d) regimen, both orally administered in a 28-d cycle, until a dose regimen is selected, with a plan to treat ∼110 pts at the selected dose. The primary end point is objective response rate. Progression-free survival, duration of response, overall survival, safety, biomarker, and pharmacokinetic assessments are secondary end points. Enrollment is ongoing at 107 sites in 13 countries (NCT02365597).

Clinical trial identification

NCT02365597

Legal entity responsible for the study

Janssen Research & Development, LLC

Funding

Janssen Research & Development, LLC

Disclosure

A.O. Siefker-Radtke: Participated in scientific advisory committees for Janssen, Eisai, and Genentech, received honoraria from Genentech, and her institution received clinical trial funding from Janssen, Millennium, Genentech, and AstraZeneca. K. Decaestecker: Received research funding from Janssen R&D, Beerse, Belgium. J.M. Burke: Participated in advisory boards or been a consultant for Gilead, Incyte, Takeda, Janssen, and Pfizer, and has received travel grant funds with TG Therapeutics. A. O'Hagan, A. Avadhani, B. Zhong, A. Santiago-Walker, P. De Porre, S. Brookman-May: Employee of Janssen R & D and holds stock in Johnson & Johnson. All other authors have declared no conflicts of interest.

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