In patients with metastatic urothelial carcinoma and FGFR alterations after previous immune checkpoint treatment, the pan–fibroblast growth factor receptor (FGFR) inhibitor erdafitinib significantly increased overall survival, compared with chemotherapy, researchers report. Erdafitinib is currently approved for the treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3/2 alterations who have progression after platinum-containing chemotherapy. The current trial, THOR, looked at the use of the agent in patients who were not able to take platinum-containing chemotherapy and instead received programmed cell death protein 1 (PD-1) and programmed death ligand 1 (PD-L1) inhibitors.
In the global phase 3 trial, patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after 1 or 2 previous treatments that included an anti–PD-1 or anti–PD-L1 were randomized to erdafitinib or the investigator’s choice of chemotherapy (docetaxel or vinflunine).
Based on a primary endpoint of overall survival, the investigators found: “A total of 266 patients underwent randomization: 136 to the erdafitinib group and 130 to the chemotherapy group. The median follow-up was 15.9 months. The median overall survival was significantly longer with erdafitinib than with chemotherapy (12.1 months vs. 7.8 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.47 to 0.88; P = 0.005). The median progression-free survival was also longer with erdafitinib than with chemotherapy (5.6 months vs. 2.7 months; hazard ratio for progression or death, 0.58; 95% CI, 0.44 to 0.78; P <0.001). The incidence of grade 3 or 4 treatment-related adverse events was similar in the two groups (45.9% in the erdafitinib group and 46.4% in the chemotherapy group). Treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (in 0.7% vs. 5.4% of patients).”