Johnson & Johnson subsidiary Janssen Pharmaceutical has reported positive results from the BLC2001 trial, a Phase ll study evaluating the efficacy and safety of erdafitinib to treat patients with metastatic or surgically unresectable urothelial cancer (mUC) and FGFR alterations (FGFRalt).

Around 210 patients were enrolled in the multi-centre, open-label trial.

As part of the trial, 99 patients were treated with an optimised dosing schedule employing pharmacodynamically guided dose up-titration, including a starting dose of erdafitinib at 8mg daily, with the possibility to increase the dose to 9mg daily based on serum phosphate levels.

Approximately 12% of the trial’s patients were chemo-naïve, while 89% had received one or more lines of therapy, 43% of the patients received two or more prior lines of therapy, and 78% had visceral metastases.

Results of the study reported a 40% confirmed overall response rate, a median progression-free survival of 5.5 months and median overall survival of 13.8 months.

“Additionally, there is no targeted therapy approved for treating specific subsets of patients with urothelial cancer who have genetic alterations.”

The most common grade 3 adverse events (AEs) experienced by the patients included hand-foot syndrome (5%) and diarrhea (4%), while seven patients discontinued the trial due to treatment-related AEs.

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BLC2001 trial lead investigator Arlene Siefker-Radtke said: “Despite the improvements in outcomes reported with immune checkpoint inhibitors, the majority of patients do not respond to treatment.

“Additionally, there is no targeted therapy approved for treating specific subsets of patients with urothelial cancer who have genetic alterations.

“These encouraging Phase ll data showed treatment with erdafitinib resulted in promising response rates and progression-free survival in an important patient population.”

Erdafitinib is a once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor currently under investigation by Janssen Research & Development for treating patients with advanced urothelial cancer.