Treatment with the FGFR inhibitor erdafitinib in patients with metastatic bladder cancers marked by mutations in the FGFR3 gene resulted in a 40% overall response rate (ORR) and was well-tolerated, according to an international Phase II trial led by The University of Texas MD Anderson Cancer Center, Houston.
The trial results, published in the New England Journal of Medicine, led to approval of erdafitinib earlier this year by the Food and Drug Administration, making it the first targeted therapy approved for treating patients with advanced bladder cancer.
The oral targeted therapy also achieved a 59% ORR in patients for whom immunotherapy previously had failed, indicating this may be a viable option for these patients in need of alternative treatments.
"Patients have been in desperate need for alternative strategies, especially when a large number of them cannot tolerate the current standards of care," says Arlene Siefker-Radtke, professor of genitourinary medical oncology. "We were very gratified to see a 40% response rate in patients treated on this clinical trial. Not only did it work well in patients with lymph node metastases, but in those with high volume and very aggressive disease."
Standard of care for these cancers is...