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

James W.F.  Catto; Ben Tran; Viraj A. Master; Morgan Roupret; Geraldine Pignot; Andrea Tubaro; Nobuaki Shimizu; Nikhil Vasdev; Juergen Gschwend; Yohann Loriot; Hiyoyuki Nishiyama; Joan Redorta; Siamak Daneshmand; Yuji Miura; Vahid Naini; Lauren Crow; Spyros Triantos; Mahadi Baig; Gary D. Steinberg

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

James W.F. Catto, Ben Tran, Viraj A. Master, Morgan Roupret, Geraldine Pignot, Andrea Tubaro, Nobuaki Shimizu, Nikhil Vasdev, Juergen Gschwend, Yohann Loriot, Hiyoyuki Nishiyama, Joan Redorta, Siamak Daneshmand, Yuji Miura, Vahid Naini, Lauren Crow, Spyros Triantos, Mahadi Baig, Gary D. Steinberg

Research output: Contribution to conference › Poster › peer-review

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.

Original language	English
Publication status	Published - 17 Feb 2023
Event	ASCO Genitourinary Cancers Symposium - 2023 Moscone West • San Francisco, CA , United States Duration: 16 Feb 2023 → 18 Feb 2023 https://conferences.asco.org/gu/program

Conference

Conference	ASCO Genitourinary Cancers Symposium
Country/Territory	United States
Period	16/02/23 → 18/02/23
Internet address	https://conferences.asco.org/gu/program

Embargoed Document

ASCO GU poster Cohort 2_ 25Jan23_STA
Accepted author manuscript, 638 KB

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Catto, J. W. F., Tran, B., Master, V. A., Roupret, M., Pignot, G., Tubaro, A., Shimizu, N., Vasdev, N., Gschwend, J., Loriot, Y., Nishiyama, H., Redorta, J., Daneshmand, S., Miura, Y., Naini, V., Crow, L., Triantos, S., Baig, M., & Steinberg, G. D. (2023). 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. Poster session presented at ASCO Genitourinary Cancers Symposium, United States.

Catto, James W.F. ; Tran, Ben ; Master, Viraj A. et al. / 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. Poster session presented at ASCO Genitourinary Cancers Symposium, United States.

@conference{2951fb65f6dd451181355e3e7186fd4d,

title = "Phase 2 Study of the Efficacy and Safety of Erdafitinib in Patients With Bacillus Calmette-Gu{\'e}rin (BCG)-Unresponsive, High-Risk Non–Muscle-Invasive Bladder Cancer (HR-NMIBC) With FGFR3/2 Alterations (alt) in THOR-2: Cohort 2 Interim Analysis Results",

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.",

author = "Catto, {James W.F.} and Ben Tran and Master, {Viraj A.} and Morgan Roupret and Geraldine Pignot and Andrea Tubaro and Nobuaki Shimizu and Nikhil Vasdev and Juergen Gschwend and Yohann Loriot and Hiyoyuki Nishiyama and Joan Redorta and Siamak Daneshmand and Yuji Miura and Vahid Naini and Lauren Crow and Spyros Triantos and Mahadi Baig and Steinberg, {Gary D.}",

year = "2023",

month = feb,

day = "17",

language = "English",

url = "https://conferences.asco.org/gu/program",

}

Catto, JWF, Tran, B, Master, VA, Roupret, M, Pignot, G, Tubaro, A, Shimizu, N, Vasdev, N, Gschwend, J, Loriot, Y, Nishiyama, H, Redorta, J, Daneshmand, S, Miura, Y, Naini, V, Crow, L, Triantos, S, Baig, M & Steinberg, GD 2023, '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', ASCO Genitourinary Cancers Symposium, United States, 16/02/23 - 18/02/23.

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. / Catto, James W.F. ; Tran, Ben; Master, Viraj A. et al.
2023. Poster session presented at ASCO Genitourinary Cancers Symposium, United States.

Research output: Contribution to conference › Poster › peer-review

TY - CONF

T1 - 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

AU - Catto, James W.F.

AU - Tran, Ben

AU - Master, Viraj A.

AU - Roupret, Morgan

AU - Pignot, Geraldine

AU - Tubaro, Andrea

AU - Shimizu, Nobuaki

AU - Vasdev, Nikhil

AU - Gschwend, Juergen

AU - Loriot, Yohann

AU - Nishiyama, Hiyoyuki

AU - Redorta, Joan

AU - Daneshmand, Siamak

AU - Miura, Yuji

AU - Naini, Vahid

AU - Crow, Lauren

AU - Triantos, Spyros

AU - Baig, Mahadi

AU - Steinberg, Gary D.

PY - 2023/2/17

Y1 - 2023/2/17

N2 - 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.

AB - 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.

M3 - Poster

T2 - ASCO Genitourinary Cancers Symposium

Y2 - 16 February 2023 through 18 February 2023

ER -

Catto JWF, Tran B, Master VA, Roupret M, Pignot G, Tubaro A et al.. 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. 2023. Poster session presented at ASCO Genitourinary Cancers Symposium, United States.