Real-world study on the application of FGFR inhibitors in metastatic bladder cancer: A multinational analysis.

e23306 Background: Metastatic urothelial cancer is an aggressive disease with a poor prognosis. Recent advances in the molecular characterization of urothelial cancer have led to the development and approval of targeted therapies. FGFR3 biomarker testing is recommended by all guidelines for treatment decision-making. Erdafitinib is approved by regulatory agencies worldwide, particularly for patients who have been exposed to chemotherapy and immune-checkpoint inhibitors. Other compounds are being investigated in clinical trials. However, there is a lack of real-world data regarding the use of FGFR inhibitors (FGFRi) in clinical practice. Methods: This study utilized IQVIA’s Oncology Dynamics, an oncology-specific, multi-country, cross-sectional survey, which collects patient-level oncology data using anonymized records of drug-treated cancer patients. Bladder cancer patients in the US, EU4 (France, Germany, Italy, Spain) + UK, and APAC (China, Japan, Korea) between January 2017 and September 2024 were evaluated for biomarker testing, demographics characteristics, and treatment options. Results: A comprehensive analysis was conducted on 22,154 patients with metastatic bladder cancer. The cohort comprised 12,768 patients from Europe, 8,016 from the USA, and 1,370 from the APAC region. Among these patients, 1,646 (7.4%) were FGFR positive. The FGFR positivity rates were 5.9% in the USA, 4.3% in Europe, and 0.47% in APAC. The majority of these patients were female (56.5%), and the most common age at diagnosis was between 71-75 years (31.5%). Of the FGFR-positive patients, only 20% received targeted treatment. The distribution of these treatments was predominantly in the USA (249 patients), followed by Europe (52 patients) and APAC (1 patient). Erdafitinib was the most frequently administered drug. Public funding covered the treatment costs for 83.3% of all patients. FGFR inhibitors were used as first-line systemic therapy in 31% of the patients, with a higher proportion in Europe (51%) compared to the USA (27.3%). Additionally, 69% of the patients received FGFRi as third-line or later treatments, with 76% of these patients having previously undergone immunotherapy. Overall, only 11.9% of the patients participated in clinical trials, with a significantly higher participation rate in Europe (61%) compared to the USA (0.5%). Conclusions: FGFR inhibitors are recommended by international guidelines for FGFR3-altered bladder cancer patients, but our data suggests limited access worldwide in clinical practice despite regulatory approvals and guideline recommendations. There is geographic variation in the percentage of patients treated with FGFRi, suggesting higher access in the USA. Potential reasons include drug cost limiting access, approval delays in different regions, and recent approvals of ADCs. Additional research is needed to address the best treatment sequencing in mBC.