Abstract 774P
Background
Immune checkpoint, PD-1/PD-L1, inhibitors have recently received European regulatory approvals for the treatment of locally advanced to metastatic urothelial carcinoma in the post-platinum setting, regardless of PD-1/PD-L1 status. Pembrolizumab and atezolizumab have also been approved as first-line therapies in cisplatin-ineligible patients whose tumors express high levels of PD-1/PD-L1. This study aims to understand the impact of ICI approvals in locally advanced to metastatic bladder cancer and the profile of patients currently receiving them.
Methods
This study was conducted using Oncology Dynamics™, an IQVIA oncology cross-sectional survey collecting anonymized real-world patient-level data. 5,797 bladder cancer patients in locally advanced to metastatic stages from January 2017 to December 2019 in EU5 (France, Germany, Spain, Italy, UK) were identified and multivariable analysis of their data was performed. Objective was to assess adoption of ICIs in platinum-refractory and first line patients.
Results
Use of ICIs increased by 30% in platinum-refractory patients (n=867) from 2017 to 2018, reaching 71% share in 2018. Patients not receiving ICIs were observed to be older, with worse ECOG status and higher prevalence of comorbidities such as autoimmune disease and cardiac dysfunction, as compared to patients on ICIs. In first-line setting (n=4,621), prescription of ICIs increased from 2% in 2017 to 16% in 2018, and further reached 19% in 2019. In patients not positive for PD-1/PD-L1, use of ICIs increased from 1% in 2017 to 10% in 2018 and decreased to 4% in 2019. The recent decline could be due to the 2018 EMA guideline update, restricting the first-line use of ICIs to patients with high levels of PD-1/PD-L1. In 2019, amongst patients receiving ICIs in first line 12% were receiving ICIs off-label. 46% of ICI receiving patients reported no side effects, though only 27% of non-ICI receiving patients were side effect free.
Conclusions
Influenced by regulatory approvals and clinical guideline recommendations ICIs have had a rapid adoption, prompting a paradigm shift in bladder cancer treatment in EU5. Some off-label use of ICIs can also be observed in first line setting.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
IQVIA Ltd.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.