Erdafitinib boosted survival in patients with certain conditions including metastatic urothelial carcinoma.
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced results from an interim analysis of its phase 3 THOR study.
Emerging data from the trial cohort duly demonstrated more than a four-month improvement in median overall survival among patients treated with erdafitinib versus chemotherapy.
The research is evaluating treatment with erdafitinib versus chemotherapy among patients with metastatic or unresectable urothelial carcinoma (UC) and selected fibroblast growth factor receptor (FGFR) gene alterations.
The patients in question had also received prior treatment with an anti-programmed death-ligand agent.
THOR is a randomised, open-label, multicentre study evaluating the efficacy and safety of erdafitinib. Patients were categorised into one of two cohorts based on the type of prior therapy they had received.
During the study, 136 patients were assigned to erdafitinib and 130 were randomised to chemotherapy.
Ultimately, the study also met its primary endpoint of overall survival (OS) and reduced the risk of death by 36%. Meanwhile, the safety profile of erdafitinib witnessed throughout THOR has been consistent with the known safety profile in metastatic UC.
Yohann Loriot, from the University of Paris-Saclay and principal study investigator, reflected: “These results represent the first data from a randomised, controlled trial evaluating erdafitinib for the treatment of patients with FGFR-altered UC, who often experience poor disease outcomes.”
He added: “The use of erdafitinib in this setting supports recommendations for FGFR testing in all patients with metastatic UC.”
Martin Vogel, EMEA therapeutic area lead oncology at Janssen-Cilag GmbH, concluded: “Bladder cancer, of which UC is the most common form, carries a high burden of disease for patients. Europe has the second highest rates of bladder cancer in the world, with over 203,000 patients diagnosed in 2020 alone.”