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Pan-FGFR TKI Shows Favorable Efficacy in Advanced Urothelial Cancer

A phase 2 study of erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor (TKI), continues to demonstrate long-term efficacy and tolerable safety in patients with advanced or metastatic urothelial carcinoma.

A total of 212 patients were enrolled to the international trial conducted in 126 medical centers ranging from Asia, Europe, and North America. In all, 101 patients were treated with erdafitinib 8 mg once a day orally in 28-day cycles with provision for pharmacodynamically guided uptitration to 9 mg once a day regimen.

The primary endpoint of the trial was investigator-assessed confirmed objective response rate (ORR) and safety in all treated patients who received at least 1 dose of erdafitinib.

“Median efficacy follow-up was 24 months (IQR, 22.7-26.6). The investigator-assessed ORR for patients treated with erdafitinib was 40 (95% CI, 30-49) of 101 patients,” explained Arlene O. Siefker-Radtke, MD, The University of Texas, MD Anderson Cancer Center, and co-researchers.

No new safety signals or deaths were reported with longer follow-up, meaning erdafitinib had a safety profile shown during the primary analysis.

Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 71% of patients. The most common grade 3 or higher TEAEs were stomatitis in 14% of patients and hyponatremia in 11%.

“With longer follow-up, treatment with the selected regimen of erdafitinib showed consistent activity and a manageable safety profile in patients with locally advanced or metastatic urothelial carcinoma and prespecified FGFR alterations,” concluded Dr Siefker-Radtke, et al.—Alexa Stoia

 

Siefker-Radtke AO, Necchi A, Park SH, et al. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. 2022;23(2):248-258. doi:10.1016/S1470-2045(21)00660