Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial

ABACUS is a single arm phase 2 study that investigated 2 cycles of atezolizumab (1200mg Q3) prior to cystectomy in 95 patients with muscle invasive transitional cell cancer (T2-4N0M0). Pathological complete response (pCR) occurring in ≥20% of patients was the primary endpoint. Biomarker analysis on sequential tissue was a co-primary endpoint.EGA study EGAS00001004445

ABACUS是一项单臂Ⅱ期临床试验，共纳入95例肌肉浸润性移行细胞癌（muscle invasive transitional cell cancer，T2-4N0M0）患者，评估在膀胱切除术术前给予2个周期阿替利珠单抗（atezolizumab，1200mg，每3周1次）的治疗方案。该试验的主要终点为患者中达到病理完全缓解（pathological complete response, pCR）的比例≥20%；对序贯采集的肿瘤组织进行生物标志物分析则为共同主要终点。本试验隶属于EGA研究（EGAS00001004445）