ESMO 2023: Erdafitinib Improves Overall Survival in Patients With Metastatic Urothelial Carcinoma
Results of THOR cohort 1 trial confirm effects on patients with FGFR alterations
MONDAY, Oct. 30, 2023 (HealthDay News) -- Erdafitinib therapy resulted in significantly better patient outcomes compared with chemotherapy among patients with metastatic urothelial carcinoma and pan-fibroblast growth factor receptor (FGFR) alterations following treatment with anti-programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) agents, according to a study published online Oct. 21 in the New England Journal of Medicine to coincide with the annual meeting of the European Society for Medical Oncology, held from Oct. 20 to 24 in Madrid, Spain.
Yohann Loriot, M.D., Ph.D., of the Université Paris-Saclay, and colleagues evaluated data from the THOR cohort 1 trial to confirm the effects of erdafitinib in patients with FGFR-altered metastatic urothelial carcinoma who had progression during or after treatment with PD-1 and PD-L1 checkpoint inhibitors. Patients were randomly assigned 1:1 to receive either erdafitinib (136 patients) or the investigator’s choice of chemotherapy (130 patients; docetaxel or vinflunine).
The researchers found that during a median 15.9 months of follow-up, overall survival was significantly longer with erdafitinib versus chemotherapy (12.1 versus 7.8 months; hazard ratio [HR] for death, 0.64; 95 percent confidence interval [CI], 0.47 to 0.88; P = 0.005). Progression-free survival was also longer with erdafitinib versus chemotherapy (5.6 versus 2.7 months; HR for progression or death, 0.58; 95 percent CI, 0.44 to 0.78; P < 0.001).
Both groups had similar incidence rates of grade 3 or 4 treatment-related adverse events (45.9 percent in the erdafitinib group versus 46.4 percent in the chemotherapy group), while treatment-related adverse events that led to death were less common with erdafitinib than with chemotherapy (0.7 versus 5.4 percent, respectively).
“These phase 3 results show the clinical benefit of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma with FGFR alterations after anti-PD-1 or anti-PD-L1 treatment,” the authors write. “These data further support the recommendation for molecular testing in patients with metastatic urothelial carcinoma to identify those with FGFR alterations who may benefit from erdafitinib.”
THOR cohort 2 is ongoing. “We are examining erdafitinib as compared with pembrolizumab in patients who had not previously received an anti-PD-1 or anti-PD-L1 agent,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry, including Janssen Research and Development, which funded the study.
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