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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
