Additional treatment options are needed for patients with advanced or metastatic urothelial cancer who have disease progression after standard therapy. The THOR trial compared erdafitinib, a pan–fibroblast growth factor receptor (FGFR) inhibitor, with chemotherapy for the treatment of patients with advanced or metastatic urothelial carcinoma harbouring FGFR alterations and with disease progression during or after treatment with checkpoint inhibitors. The results demonstrate that erdafitinib significantly extends survival compared to chemotherapy in these patients.
Additional treatment options are needed for patients with advanced or metastatic urothelial cancer whose disease progresses after standard therapy. Erdafitinib is a pan–fibroblast growth factor receptor (FGFR) inhibitor approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations with disease progression after platinum-containing chemotherapy. However, the effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who have progression during or after treatment with checkpoint inhibitors (anti–programmed cell death protein 1 [PD-1] or anti–programmed death ligand 1 [PD-L1] agents) are unclear. To address this gap, this study compared erdafitinib and chemotherapy treatments in this patient population.
Methods
The multinational phase 3 THOR trial included adult patients with metastatic or surgically unresectable urothelial cancer with selected FGFR2 or FGFR3 alterations and progression after one or two previous treatments that included an anti–PD-1 or anti–PD-L1 therapy. In total, 266 patients were randomly assigned (1:1) to receive to receive erdafitinib (n=136) or the investigator’s choice of chemotherapy (docetaxel or vinflunine, n=130). Treatment was administered in 21-day cycles every 3 weeks until disease progression or unacceptable toxic effects. The primary endpoint was overall survival (OS).
Study findings
After a median follow-up of 15.9 months, erdafinib significantly prolonged OS compared to chemotherapy (HR[95%CI]: 0.64[0.47-0.88]; p=0.005), with a median OS of 12.1 vs. 7.8 months in patients receiving erdafinib and chemotherapy, respectively. The median progression-free survival was improved with erdafitinib (5.6 vs. 2.7 months with chemotherapy; HR[95%CI]: 0.58[0.44-0.78]; p<0.001). Objective response rate was reported at 45.% vs. 11.5% in those patients receiving erdafitinib and chemotherapy, respectively.
In summary, these results indicate that erdafitinib leads to a significantly longer OS compared to chemotherapy in patients with metastatic urothelial carcinoma and FGFR alterations after previous anti–PD–1 or anti–PD-L1 treatment.
Reference
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