FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression

Sternberg, Cora N; Petrylak, Daniel P; Bellmunt, Joaquim; Nishiyama, Hiroyuki; Necchi, Andrea; Gurney, Howard; Lee, Jae-Lyun; Van Der Heijden, Michiel S; Rosenbaum, Eli; Penel, Nicolas; Pang, See-Tong; Jian-Ri, Li; García Del Muro, Xavier; Joly, Florence; Pápai, Zsuzsanna; Bao, Weichao; Ellinghaus, Peter; Chengxing, Lu; Sierecki, Mitchell; Coppieters, Sabine; Nakajima, Keiko; Ishida, Tatiane Cristine; Quinn, David I

doi:10.1200/JCO.21.02303

Rogaratinib, an oral pan-fibroblast growth factor receptor (FGFR1-4) inhibitor, showed promising phase I efficacy and safety in patients with advanced urothelial carcinoma (UC) with FGFR1-3 mRNA overexpression. We assessed rogaratinib efficacy and safety versus chemotherapy in patients with FGFR mRNA-positive advanced/metastatic UC previously treated with platinum chemotherapy.

FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression / Sternberg, C.N., Petrylak, D.P., Bellmunt, J., Nishiyama, H., Necchi, A., Gurney, H., Lee, J., Van Der Heijden, M.S., Rosenbaum, E., Penel, N., Pang, S., Li, J., García Del Muro, X., Joly, F., Pápai, Z., Bao, W., Ellinghaus, P., Lu, C., Sierecki, M., Coppieters, S., et al.. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - 41:3(2023), pp. 629-639. [10.1200/JCO.21.02303]