European urology · 2025
Erdafitinib in Patients with High- and Intermediate-risk Non-muscle-invasive Bladder Cancer: Final Analysis of THOR-2 Study.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Daneshmand Siamak, Zaucha Renata, Catto James W F, Tran Ben, Master Viraj, Lotan Yair, Pignot Geraldine, Tubaro Andrea, Shimizu Nobuaki, Vasdev Nikhil, Lee Eugene K, Procopio Giuseppe, Galanternik Fernando, Crow Lauren, Deprince Kris, Naini Vahid, Triantos Spyros, Baig Mahadi, Zhu Wei, Maranchie Jodi K
Аннотация
BACKGROUND AND OBJECTIVE: High-risk (HR) or intermediate-risk (IR) non-muscle-invasive bladder cancer (NMIBC) carries a high probability of recurrence and/or progression. We present the final analysis results of erdafitinib in HR- or IR-NMIBC with fibroblast growth factor receptor 3/2 alterations (FGFR3/2alt) from the phase 2 THOR-2 study.
METHODS: Cohort 1 (HR-NMIBC papillary only) with prior bacillus Calmette-Guérin was randomized 2:1 to erdafitinib or intravesical chemotherapy. Cohorts 2 (carcinoma in situ ± papillary) and 3 (IR-NMIBC) received erdafitinib. The primary endpoint was recurrence-free survival (RFS) for cohort 1. Exploratory endpoints included complete response (CR) rate and duration of response (DoR) for cohorts 2 and 3.
KEY FINDINGS AND LIMITATIONS: In cohort 1 (n = 73), median RFS was not reached (NR) for erdafitinib (95% confidence interval [CI] 28.6 mo-not estimable [NE]) and 11.6 mo (95% CI 5.3-NE) for intravesical chemotherapy (hazard ratio 0.28 [95% CI 0.13-0.61; nominal p = 0.0007]; median follow-up, 18.5 and 16.6 mo, respectively). In cohort 2 (n = 16), CR rates were 94% (95% CI 70-100%) and 81% (95% CI 54-96%) at 8 and 32 wk, respectively; the median DoR (mDoR) was 23.3 mo (95% CI 10.0-NE; n = 15). In cohort 3 (n = 18), the CR rate was 89% (95% CI 65-99%) and mDoR was NR (95% CI 13.4 mo-NE). Most common treatment-related adverse event in pooled erdafitinib cohorts (N = 83) was hyperphosphatemia (76%). Limitations include early termination in cohort 1 and small sample size that precluded prespecified hypothesis testing.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Oral erdafitinib demonstrated high efficacy in FGFR3/2alt HR-/IR-NMIBC, with a manageable safety profile.
METHODS: Cohort 1 (HR-NMIBC papillary only) with prior bacillus Calmette-Guérin was randomized 2:1 to erdafitinib or intravesical chemotherapy. Cohorts 2 (carcinoma in situ ± papillary) and 3 (IR-NMIBC) received erdafitinib. The primary endpoint was recurrence-free survival (RFS) for cohort 1. Exploratory endpoints included complete response (CR) rate and duration of response (DoR) for cohorts 2 and 3.
KEY FINDINGS AND LIMITATIONS: In cohort 1 (n = 73), median RFS was not reached (NR) for erdafitinib (95% confidence interval [CI] 28.6 mo-not estimable [NE]) and 11.6 mo (95% CI 5.3-NE) for intravesical chemotherapy (hazard ratio 0.28 [95% CI 0.13-0.61; nominal p = 0.0007]; median follow-up, 18.5 and 16.6 mo, respectively). In cohort 2 (n = 16), CR rates were 94% (95% CI 70-100%) and 81% (95% CI 54-96%) at 8 and 32 wk, respectively; the median DoR (mDoR) was 23.3 mo (95% CI 10.0-NE; n = 15). In cohort 3 (n = 18), the CR rate was 89% (95% CI 65-99%) and mDoR was NR (95% CI 13.4 mo-NE). Most common treatment-related adverse event in pooled erdafitinib cohorts (N = 83) was hyperphosphatemia (76%). Limitations include early termination in cohort 1 and small sample size that precluded prespecified hypothesis testing.
CONCLUSIONS AND CLINICAL IMPLICATIONS: Oral erdafitinib demonstrated high efficacy in FGFR3/2alt HR-/IR-NMIBC, with a manageable safety profile.