The results of a clinical trial evaluating individuals with metastatic or unresectable bladder cancer treated with the novel precision cancer medicine, erdafitinib were recently published and suggest this pan-fibroblast growth factor receptor (FGFR) inhibitor has significant anti-cancer activity. These results come just a few months after the FDA granted Breakthrough Therapy Designation to erdafitinib for patients with metastatic bladder cancer.
About Bladder Cancer
Bladder cancer will be diagnosed in approximately 77,000 people in the United States this year alone. The average age that patients are diagnosed with bladder cancer is 70 years, with 80% of these patients being former smokers. The most common type of bladder cancer is urothelial carcinoma, whereby cancer begins in the cells that line the bladder.
Urothelial carcinoma may involve parts of the kidney, bladder, and ureter (the tube that connects the kidney to the bladder). Urothelial carcinomas begin in the cells that line the particular organ in which the cancer develops. If detected and treated early, cure rates are high. However, once bladder cancer has spread outside of the bladder to distant sites in the body, effective treatment options remain limited, particularly if a patient experiences a cancer recurrence following prior therapies. Advanced bladder cancer refers to cancer that has spread outside the bladder to regional or distant sites in the body.
Because the majority of patients diagnosed with bladder cancer are elderly and/or former smokers, they are often too frail to be treated with the standard chemotherapy drug approved for the treatment of advanced stages of this disease, cisplatin. Patients who are not able to tolerate cisplatin may be treated with the chemotherapy agent carboplatin, which provides a median survival of approximately 9-10 months.
About ErdafitinibErdafitinib is an oral pan-fibroblast growth factor receptor tyrosine kinase inhibitor being evaluated in Phase 2 and 3 clinical trials in patients with advanced urothelial cancer. FGFRs are a family of receptor tyrosine kinases which may be upregulated in various tumor cell types and may be involved in tumor cell differentiation and proliferation, tumor angiogenesis, and tumor cell survival.
The current clinical trial enrolled advanced bladder cancer patients with FGFR alterations, and 99 were treated with a median of 5 cycles of erdafitinib. Participants with prior treatment with immune check point inhibitors were also eligible to participate in the study.
Overall 40% of patients responded to treatment: 3% of patients had a complete response and 37% a partial response. According to the study presenter Arlene Siefker-Radtke, MD, Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “This [trial] had a very impressive response rate in people that were pretty heavily pre-treated, and it was interesting that some of the patients who responded to this drug were resistant to immune checkpoint inhibitors,”
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