MP59-19 UPDATE OF TRUCE-02: AN OPEN LABEL, SINGLE-ARM, PHASE 2 STUDY OF TILELIZUMAB COMBINED WITH NAB-PACLITAXEL FOR HIGH-RISK NON-MUSCLE-INVASIVE UROTHELIAL BLADDER CARCINOMA (HR-NMIBC) WHICH IS NOT COMPLETELY RESECTABLE

Abstract

You have accessJournal of UrologyCME1 May 2022MP59-19 UPDATE OF TRUCE-02: AN OPEN LABEL, SINGLE-ARM, PHASE 2 STUDY OF TILELIZUMAB COMBINED WITH NAB-PACLITAXEL FOR HIGH-RISK NON-MUSCLE-INVASIVE UROTHELIAL BLADDER CARCINOMA (HR-NMIBC) WHICH IS NOT COMPLETELY RESECTABLE Hailong Hu, Yuanjie Niu, Haitao Wang, Chong Shen, La Da, Gangjian Zhao, Lili Wang, Zhouliang Wu, Zhe Zhang, Zhi Li, Zhan Jiang, Xuejian Zhan, and Shaobo Yang 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 , La DaLa Da More articles by this author , Gangjian ZhaoGangjian Zhao More articles by this author , Lili WangLili Wang More articles by this author , Zhouliang WuZhouliang Wu More articles by this author , Zhe ZhangZhe Zhang More articles by this author , Zhi LiZhi Li More articles by this author , Zhan JiangZhan Jiang More articles by this author , Xuejian ZhanXuejian Zhan More articles by this author , and Shaobo YangShaobo Yang More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002642.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Phase 2 study KEYNOTE-057 showed that pembrolizumab (pembro) monotherapy has its efficiency of antitumor treatment and acceptable safety in BCG-unresponsive HR-NMIBC pts. PEANUT study showed that with the combination of pembro and nab-paclitaxel had a low AE rate (adverse events (AE)), meanwhile, with considerable CR rate in the 2nd-line treatment of bladder cancer. Tilelizumab was proved its efficiency in locally advanced or metastatic urothelial carcinoma. We report preliminary treatment efficiency, safety data and exploratory work of the TRUCE-02 trail(NCT04730232). METHODS: TRUCE-02 is an Open Label, Single-arm, Phase 2 Study for pts with un-completely resectable HR-NMIBC. Pts received 3 or 4 cycles of Tislelizumab plus nab-paclitaxel Q3W followed by resection biopsy. Primary endpoint is CR rate. Meanwhile, we sent biospecimens of pts’ tumor before treatment to analyze Acornmed panel targeting 808 cancer-related hotspot genes. PD-L1 expression was measured by immunohistochemistry staining. We analyzed WGS from pts’ urine sediments. RESULTS: To date, 51 pts have been recruited. 32 pts have completed the whole 3 or 4 treatment cycles and reached the primary endpoint. Median age was 67 (range=44-85). 25 pts were male. 14 pts were combined with Tis. Evaluable analysis at this time shows, CR rate of 62.5% (N=20/32), PR rate of 12% (N=4/32), SD rate of 16% (N=5/32), PD rate of 9% (N=3/32). Low-grade treatment-related AEs include alopecia (81%), fatigue (34%). All other AEs were seen at 7% or less. 2 pts had immune-related severe AEs including cytokine release syndrome (3%), papular and pustular rash (3%). To date, 4/32 (12.5%) pts proceed to cystectomy. As for PD-L1 expression, 50% (N=12/24) of response pts (CR+PR) showed positive, 38% (N=3/8) of un-response pts (PD+SD) showed positive. We found out that HRR mutation may predict a favorable prognosis. The uniformity of the WGS results in urine and tumor tissue were verified considerable. CONCLUSIONS: With a CR rate of 62.5%, high-grade AE rate lower than 5%, this treatment plan has shown its efficiency and safety in pts with un-completely resectable NMIBC by TUR-BT. We also found that the efficacy of this treatment does not depend on the expression of PD-L1. Source of Funding: The present study received financial support from the Natural Science Foundation Project of Tianjin (grant no.18PTLCSY00010), the Tianjin Urological Key Laboratory Foundation (grant no.2017ZDSYS13) © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1010 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 La Da More articles by this author Gangjian Zhao More articles by this author Lili Wang More articles by this author Zhouliang Wu More articles by this author Zhe Zhang More articles by this author Zhi Li More articles by this author Zhan Jiang More articles by this author Xuejian Zhan More articles by this author Shaobo Yang More articles by this author Expand All Advertisement PDF DownloadLoading ...