ONCAlert | 2018 ASCO Annual Meeting

Discussion on Trial Investigating Erdafitinib in Patients With Urothelial Cancer

Arlene O. Siefker-Radtke, MD
Published Online: 5:46 PM, Fri June 8, 2018


Arlene O. Siefker-Radtke, MD, professor of genitourinary medical oncology at MD Anderson Cancer Center, discusses the results presented at the 2018 ASCO Annual Meeting from a phase II cohort investigating erdafitinib in previously treated patients with urothelial cancer. Erdafitinib is a fibroblast growth factor receptor (FGFR) inhibitor that targets FGFR 1 through 4 and has previously shown promising activity. 

This trial was designed to investigate options for a population that is in need of a new agent after previously receiving an immunotherapy or chemotherapy alone. Patients with previously treated metastatic urothelial tumors were randomized to receive erdafitinib in either intermittent or continuous dosing. Initial data supported the continuous dosing regimen. 

Of 99 patients enrolled in a phase II cohort of continuous dosing at 9 mg of erdafitinib, there was a 40% objective response rate. The therapy was well tolerated with a low number of patients discontinuing due to treatment-related adverse events. The most common reason for discontinuation was progression of disease. 

Siefker-Radtke said that there was a progression-free survival rate of 5.6 months on these tumors and a median overall survival of 13.8 months. There are plans to continue investigating erdafitinib for this patient population in a larger phase III trial. She says patients with FGFR-altered tumors will be randomized to either immunotherapy or erdafitinib if they have not previously been treated, and a taxane or erdafitinib if they have previously been treated.

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