Phase 2 Study of the Efficacy and Safety of Erdafitinib in Patients With Bacillus Calmette-Guérin (BCG)-Unresponsive, High-Risk Non–Muscle-Invasive Bladder Cancer (HR-NMIBC) With FGFR3/2 Alterations (alt) in THOR-2: Cohort 2 Interim Analysis Results
Author
Catto, James W.F.
Tran, Ben
Master, Viraj A.
Roupret, Morgan
Pignot, Geraldine
Tubaro, Andrea
Shimizu, Nobuaki
Vasdev, Nikhil
Gschwend, Juergen
Loriot, Yohann
Nishiyama, Hiyoyuki
Redorta, Joan
Daneshmand, Siamak
Miura, Yuji
Naini, Vahid
Crow, Lauren
Triantos, Spyros
Baig, Mahadi
Steinberg, Gary D.
Attention
2299/26606
Abstract
Patients presenting with NMIBC carcinoma in situ (CIS) have a high risk of progression1,2FGFR inhibition may benefit patients with CIS with FGFRalt who are unresponsive to fi rst-line BCG, for whom treatment options, other than radical cystectomy, are limited3-5– Data are limited in patients with CIS only, but in the broader NMIBC population the prevalence of FGFR3alt is up to 80%6Erdafi tinib, an oral selective pan-FGFR tyrosine kinase inhibitor, is approved for locally advanced or metastatic urothelial cancer in adults with susceptible FGFR3/2alt who have progressed during or after ≥1 line of platinum-containing chemotherapy7-9 THOR-2 (NCT04172675) is a multicohort phase 2 study of erdafi tinib in patients with HR-NMIBC.