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, 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; Li, Jian-Ri; García Del Muro, Xavier; Joly, Florence; Pápai, Zsuzsanna; Bao, Weichao; Ellinghaus, Peter; Lu, Chengxing; Sierecki, Mitchell; Coppieters, Sabine; Nakajima, Keiko; Ishida, Tatiane Cristine; Quinn, David I. - In: JOURNAL OF CLINICAL ONCOLOGY. - ISSN 0732-183X. - 41:3(2023), pp. 629-639. [10.1200/JCO.21.02303]