BladderGATE: Atezolizumab + intravesical BCG (bacillus Calmette-Guerin) upfront combination in patients with high risk non-muscle invasive bladder cancer (NMIBC)—Phase I-II ONCOSUR study.

作者：Daniel Castellano, Guillermo de Velasco, Jorge Esteban-Villarrubia, Marta Dueñas, Jesús M. Paramio, Víctor G. Martínez, Carmen Gómez, Marta Rodríguez-Izquierdo, Mario Hernandez, María P. Martín, Pablo Álvarez, A. Rodrı́guez-Antolı́n, Cristian A. Suárez, Lucía Morales, Carolina Rubio, Santiago Ponce Aix, Félix Guerrero‐Ramos, ONCOSUR · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.4_suppl.595 · 被引用次数：5 · 研究领域：Bladder and Urothelial Cancer Treatments、Immune responses and vaccinations、Epigenetics and DNA Methylation

595 Background: Intravesical Bacillus Calmette-Guerin (BCG) induction + BCG maintenance after transurethral resection is the current standard of care for patients (pts) with high-risk non-muscle invasive bladder cancer (NMIBC). Recurrence rate at 2 years and 5 years are around 30-40% and 70-80% respectively. Atezolizumab is a IgG1 monoclonal antibody targeting PD-L1 and is associated with long-term durable remissions in pts with metastatic urothelial cancer (MS. van der Heijden . Eur Urol 2021) and for pts with unresponsive NMIBC (PC. Black . Eur Urol 2023) with excellent results. Atezolizumab in combination with standard BCG could provide synergistic benefit for pts with NMIBC. BladderGATE (NCT04134000) is a phase Ib-II study which evaluates the safety and efficacy of upfront atezolizumab + intravesical BCG in pts with high-risk NMIBC. Methods: Pt had confirmed histopathology of high-risk NMIBC, BCG naïve or stopped >2 years ago, WHO PS 0-2 and adequate hematologic and organ function. Dose-escalation design to identify DLT and MTD (9 pts) and to evaluate safety and efficacy in an expansion cohort (30 pts) were programed. Pt received six weekly induction instillations, and maintenance instillations at 3, 6 and 12 months + intravenously atezolizumab 1200 mg every 3 weeks, up to 1 year. Urine/blood and tissue samples were collected for translational and biomarker correlative study. Primary objective is disease free survival. Secondary objectives include safety profile and qu...