Despite most urothelial carcinomas being diagnosed at an early stage, rates of recurrence and disease progression are high and a significant proportion of patients who undergo radical surgery will experience disease recurrence.
Results from an interim analysis of cohort 1 in the phase 3 THOR trial, which evaluated Janssen’s FGFR tyrosine kinase inhibitor versus chemotherapy in patients with metastatic or unresectable urothelial carcinoma and selected FGFR gene alterations who had received prior treatment with an anti-PD-L1 agent, were presented at the American Society of Clinical Oncology annual meeting.
The study met its primary endpoint of overall survival in this cohort and reduced the risk of death by 36%. Treatment with erdafitinib also provided significantly longer progression free survival and greater overall response rate versus chemotherapy.
Overall survival benefit with erdafitinib versus chemotherapy was also consistently observed across all subgroups, the company said, and the safety profile of erdafitinib was in line with the known safety profile of the drug in metastatic urothelial carcinoma.
“This data demonstrates the potential benefit of targeted therapy in effectively inhibiting the growth of FGFR-altered tumours and provides hope that we can tailor treatment to improve outcomes for these patients," Vogel said.
These interim results met the predefined criteria for superiority, Janssen outlined, adding that the independent data safety monitoring committee have recommended the study be stopped and that all patients randomised to chemotherapy be offered the opportunity to cross-over to erdafitinib.