Treatment patterns with intravesical bacillus Calmette-Guérin (BCG) in patients with non-muscle-invasive bladder cancer (NMIBC): A real-world data analysis.

person Ran Sun J&J Innovative Medicine, Brisbane, CA info_outline Ran Sun, Bolan Linghu, Robert A. Somer, Shalaka Hampras, Sumeet Kaur Bhanvadia, Emily Scherer, Joel Greshock, Hussein Sweiti

Authors person Ran Sun J&J Innovative Medicine, Brisbane, CA info_outline Ran Sun, Bolan Linghu, Robert A. Somer, Shalaka Hampras, Sumeet Kaur Bhanvadia, Emily Scherer, Joel Greshock, Hussein Sweiti Organizations J&J Innovative Medicine, Brisbane, CA, Johnson & Johnson Innovative Medicine, Cambridge, MA, Johnson & Johnson Innovative Medicine, New Brunswick, NJ, Clinical Oncology, Johnson & Johnson Innovative Medicine, Raritan, NJ, Johnson & Johnson Innovative Medicine, Lexington, MA, Johnson & Johnson Innovative Medicine, Boston, MA, Research & Development, Johnson and Johnson Innovative Medicine, Raritan, NJ, Johnson & Johnson Innovative Medicine, Spring House, PA Abstract Disclosures Research Funding No funding sources reported Background: Intravesical BCG is the recommended first-line treatment for high-risk NMIBC patients, with a recommended minimum 1-year duration consisting of 6 doses of induction followed by multiple doses of maintenance. However, up to approximately 50% of patients experience BCG failure, often within the first 6 months. Real world treatment patterns with BCG are not well understood. This study aims to characterize real-world BCG treatment patterns and treatment failure in NMIBC patients. Methods: This retrospective cohort study utilized comprehensive claims and electronic health record (EHR) from the US HealthVerity data between Oct 2015 and Dec 2022. This analysis included patients with NMIBC who received first BCG treatment within 90 days of their bladder cancer diagnosis, with a follow-up period of ≥ 3 years post BCG treatment. A descriptive analysis of the number of doses, treatment duration, and treatment discontinuation following the BCG initiation was conducted. Treatment discontinuation was defined as a gap of more than 1 year from the last BCG dose. Initiation of subsequent therapy post BCG was reported and used as a proxy for BCG failure. Results: A total of 13,525 patients met the study criteria and initiated BCG treatment between 2015 and 2022. Of all patients, 3193 (23.6%) received < 5 BCG doses, 3854 (28.5%) received 5-7 doses, and 6478 (47.9%) received > 7 BCG doses. The overall median was 7 doses (interquartile range [IQR]: 5,14). The median duration of BCG treatment was 156 days (IQR: 36, 489). BCG was discontinued in 66.9% patients within 1 year of initiation. A total of 6182 patients (45.7%) experienced treatment failure and received subsequent treatment, with 3550 patients (57.4%) initiating next treatment within 1 year of last BCG dose. Conclusions: In a large US real-world dataset, a majority of NMIBC patients treated with BCG received ≤7 doses and discontinued treatment within < 1 year of treatment initiation. Furthermore, nearly half of patients experienced BCG failure, thereby requiring subsequent therapies. This highlights a significant unmet need for treatments with improved tolerability and efficacy profile for patients with NMIBC.