Real-world use of antibody drug conjugates (ADCs) in metastatic bladder cancer: Analysis of 10,204 patients treated in clinical practice.

Abstract

e13525 Background: Metastatic bladder cancer (mBC) is an aggressive disease, with a poor prognosis. Recently, ADCs have emerged as new treatment options, particularly in platinum refractory patients (pts). Enfortumab vedotin (EV) and Sacituzumab Govitecan (SG) are approved by regulatory agencies worldwide, and several other compounds are being investigated in clinical trials. However, there is a lack of real-world data regarding the use of ADCs in clinical practice globally. Methods: The IQVIA Oncology Dynamics (OD) database, an IQVIA oncology cross-sectional survey collecting anonymized real-world patient-level data from anonymized records of drug-treated cancer pts, was used to identify mBC pts who were treated with ADCs in the United States (US), Europe (France, Germany, Spain, Italy), the United Kingdom (UK), and the Asia-Pacific (APAC) region (Japan, China, and Korea) from January 2021 to September 2024. Results: A total of 10,204 mBC pts were identified and included in this analysis: 6,669 from EU4 + UK, 716 from APAC, and 2,819 from the US. Of all patients, only 922 (9%) were treated with any ADCs as a current or prior line of treatment, including EV, SG, Disitamab Vedotin, Tisotumab Vedotin, and Trastuzumab Deruxtecan. In the US, 18.1% of the pts received ADCs compared to 10% in APAC and 5% in the EU4 + UK. The most used drugs were Nectin-4 ADCs (792 pts) and TROP-2 ADCs (85 pts); other compounds were used in 45 pts. Most pts were male (68.4%), with the most frequent age at diagnosis being between 71 and 75 years (24.8%), and 19.8% of the pts were over 75 years old. Overall, 78.2% of all pts were treated in public hospitals; 25.6% of US pts and 11.2% of EU4 + UK pts from private setting. Additionally, 87.8% of the pts received ADCs as monotherapy, while only 12.2% received them as part of a combination regimen. ADCs were administered as first-line systemic therapy in 12.9% of pts, and 54.7% received any of the drugs as third or later lines; 62.6% of pts were previously treated with immunotherapy. In the US, 59.9% of pts received ADCs as third or later lines compared to 49% in EU4 + UK. Conclusions: ADCs represent a new therapeutic option for the treatment of mBC, but our data suggest limited access worldwide despite regulatory approvals and clinical guideline recommendations. There is a geographic variation in the percentage of patients treated with ADCs, suggesting higher access in the US. Potential reasons include drug cost limiting access and approval delays in different regions. To our knowledge, this is the largest real-world study evaluating the use of ADCs in metastatic bladder cancer patients treated in clinical practice, providing meaningful insights; however, our study has some limitations, such as potential for bias and lack of survival analysis. Additional work is planned to better assess the impact of the recent incorporation of ADCs in bladder cancer treatment.