MONDAY, Oct. 23, 2023 (HealthDay News) — For patients with metastatic urothelial carcinoma and FGFR alterations with progression after previous treatment with anti-programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) agents, erdafitinib results in significantly longer overall survival, according to a study published online Oct. 21 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the European Society for Medical Oncology, held from Oct. 20 to 24 in Madrid.
Yohann Loriot, M.D., Ph.D., from Université Paris-Saclay, and colleagues conducted a global phase 3 trial of erdafitinib compared to chemotherapy in patients with metastatic urothelial carcinoma with susceptible FGFR3/2 alterations who had progression after one or two previous treatments that included a PD-1 or PD-L1 agent. Patients were randomly assigned to erdafitinib or the investigator’s choice of chemotherapy (docetaxel or vinflunine; 136 and 130 patients, respectively) and were followed for a median of 15.9 months.
The researchers found that the median overall survival was significantly longer with erdafitinib than chemotherapy (12.1 versus 7.8 months; hazard ratio for death, 0.64), as was median progression-free survival (5.6 versus 2.7 months; hazard ratio for progression or death, 0.58). The two groups had a similar incidence of grade 3 or 4 treatment-related adverse events (45.9 and 46.4 percent, respectively). Treatment-related adverse events that led to death occurred less often with erdafitinib versus chemotherapy (0.7 versus 5.4 percent of patients).
“The overall survival benefit of erdafitinib in patients with metastatic urothelial carcinoma with FGFR alterations supports molecular testing for FGFR alterations in patients with metastatic urothelial cancer,” the authors write.
The study was funded by Janssen, the manufacturer of erdafitinib.
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