Urothelial Carcinoma: FGFR Inhibition with Rogaratinib
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FORT-1 Phase II/III Trial Results
- October 28, 2022
FORT-1 Phase II/III open-label randomized trial evaluated rogaratinib efficacy versus chemotherapy in FGFR1/3-high-expressing locally advanced and metastatic urothelial carcinoma (NCT03634943).
Trial Design
Patient Population: FGFR1/3 high-expressing, locally advanced/metastatic urothelial carcinoma
Treatment Arms (1:1 randomization):
- Rogaratinib 800 mg, 3-week cycles (n=87)
- Chemotherapy standard regimen (n=88)
Primary Endpoints: Overall survival, objective response rate
Key Efficacy Results
Objective Response Rate:
- Rogaratinib: 20.7%
- Chemotherapy: 19.3%
Median Overall Survival:
- Rogaratinib: 8.3 months
- Chemotherapy: 9.8 months
Clinical Conclusions
According to Dr. Cora N. Sternberg (Sandra and Edward Meyer Cancer Center), FGFR1/3-high-expressing urothelial carcinoma patients treated with rogaratinib demonstrate:
- Equivalent anti-tumor efficacy to chemotherapy
- Good tolerability
- Potential for FGFR mutations to serve as predictive biomarker for rogaratinib response
Data Source
https://ascopubs.org/doi/full/10.1200/JCO.21.02303
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