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Rogaratinib, an oral ubiquitan fibroblast growth factor receptor (FGFR1-4) inhibitor, has demonstrated promising phase I efficacy and safety
in patients with advanced urothelial carcinoma (UC) overexpressed with FGFR1-3 mRNA.
The study evaluated the efficacy and safety
of Rogaratinib compared with chemotherapy in patients with FGFR mRNA-positive advanced/metastatic UC.
This is a randomized, open-label phase II/III trial in which patients with locally advanced or metastatic urothelial carcinoma who had previously received ≥-line platinum-containing regimen were randomized (1:1) to receive either Rokaratinib (800 mg orally, twice daily, n=87) or chemotherapy (docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2, n=88)
。 The primary endpoints were overall survival and objective response rate
.
Overall survival and progression-free survival in both groups
The objective response rate was 20.
7% and 19.
3%
in the Rogaratinib and chemotherapy groups, respectively.
Median overall survival in the Rogaratinib and chemotherapy groups was 8.
3 months and 9.
8 months, respectively (HR 1.
11, p=0.
67).
The incidence of grade 3/4 adverse reactions in the Rogaratinib group and chemotherapy group was 43.
0%/4.
7% and 39.
0%/18.
3%,
respectively.
There were no Rogaratinib-related deaths
.
An exploratory analysis of patients with FGFR3 DNA variants showed objective response rates of 52.
4% and 26.
7%
in the Rogaratinib and control groups, respectively.
It is understood that this is the first clinical trial to compare the efficacy of directly targeted FGFR therapy and chemotherapy in FGFR-mutated urothelial carcinoma, and the trial results show that Rogaratinib has comparable efficacy and safety
to chemotherapy in urothelial carcinoma.
Exploratory analysis results suggest that FGFR3 DNA variants are associated with FGFR1/3 mRNA overexpression and may be a better predictor of
response to treatment with Rogaratinib.
Original source:
Cora N.
Sternberg, et al.
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.
J Clin Oncol.
October 14, 2022.
https://ascopubs.
org/doi/full/10.
1200/JCO.
21.
02303
