You have accessJournal of UrologyCME1 May 2022PD10-07 UPDATE OF TRUCE-01: NEOADJUVANT TISLELIZUMAB COMBINED WITH NAB-PACLITAXEL FOR MUSCLE-INVASIVE UROTHELIAL BLADDER CARCINOMA Hailong Hu, Yuanjie Niu, Haitao Wang, Chong Shen, Gangjian Zhao, La Da, Lili Wang, Zhouliang Wu, Zhi Li, Houyuan Chen, Xuejian Zhan, Zhan Jiang, and Zhe Zhang Hailong HuHailong Hu More articles by this author , Yuanjie NiuYuanjie Niu More articles by this author , Haitao WangHaitao Wang More articles by this author , Chong ShenChong Shen More articles by this author , Gangjian ZhaoGangjian Zhao More articles by this author , La DaLa Da More articles by this author , Lili WangLili Wang More articles by this author , Zhouliang WuZhouliang Wu More articles by this author , Zhi LiZhi Li More articles by this author , Houyuan ChenHouyuan Chen More articles by this author , Xuejian ZhanXuejian Zhan More articles by this author , Zhan JiangZhan Jiang More articles by this author , and Zhe ZhangZhe Zhang More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002536.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The PURE-01 and ABACUS studies has elucidated the administration of neoadjuvant immune checkpoint inhibitors in muscle-invasive bladder cancer (MIBC), with efficacy comparable to chemotherapy and less adverse events. However, the role of PD-1/PD-L1 inhibitor combining with chemotherapy remains unclear. We conduct a study to evaluate the outcome of pts treated with neoadjuvant PD-1 combined with second-line chemotherapy for MIBC. METHODS: TRUCE-01 is a phase II study of Tislelizumab combined with Nab-Paclitaxel before cystectomy or complete TURBT (cTURBT): the primary endpoint is pathologic complete response (pT0). Pts with clinical stage T2-4aN0-1M0 received tislelizumab 200mg on days 1 plus paclitaxel 200mg on days 2 every 3 weeks (Q3W) x 3 cycles followed by radical cystectomy or cTURBT. Biomarker analyses included programmed death-ligand 1 (PD-L1) expression using the combined positive score (CPS; Dako 22C3 pharmDx assay) and tumor mutational burden (TMB). Comparisons between PD-L1 expression subgroups were made via Fisher’s exact tests for categorical variables. RESULTS: Between July 2020 and July 2021, 30 pts have completed neoadjuvant treatment and received radical cystectomy (n=9, 31%) or cTURBT (n=21, 69%). Finally, 16 pts achieved pT0 (53.3%; 95% CI, 36.7% to 73.3%). As a secondary end point, downstaging to pT <2 was achieved in 21 pts (70%; 95% CI, 53.3% to 86.7%). There were 2 pts experienced grade 3-4 adverse events (CTCAE), a grade 3 rash and a grade 4 acute renal failure, both of them recovered after treating by corticosteroid. In addition, The most common grade 1-2 adverse events include alopecia (96%), fatigue (63%), hyperglycemia (33%), rash (27%), fever (17%), and Creatinine increased (13%). There was no significant correlation between PD-L1 expression and therapeutic effect. pT0 was achieved in 8 pts (61.5%) with PD-L1 positive compared with 8 pts (47%) with PD-L1 negative (P=.484). As for tumor mutational burden (TMB), response pts show high lever (P=.067). CONCLUSIONS: The early efficacy data further support the role of Tislelizumab combined with Paclitaxel as neoadjuvant therapy in MIBC, benefiting them in a higher rate of pCR without increasing frequency of serve AEs. PD-L1 expression has no obvious correlation with the efficacy of immunotherapy combined chemotherapy. Patients with high TMB are more likely to respond to neoadjuvant therapy. Enrollment is ongoing. Source of Funding: The present study received financial support from the the Natural Science Foundation Project of Tianjin (grant no. 18PTLCSY00010) © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e186 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hailong Hu More articles by this author Yuanjie Niu More articles by this author Haitao Wang More articles by this author Chong Shen More articles by this author Gangjian Zhao More articles by this author La Da More articles by this author Lili Wang More articles by this author Zhouliang Wu More articles by this author Zhi Li More articles by this author Houyuan Chen More articles by this author Xuejian Zhan More articles by this author Zhan Jiang More articles by this author Zhe Zhang More articles by this author Expand All Advertisement PDF DownloadLoading ...