Pd33-07 Neoadjuvant Toripalimab Combined With Axitinib in Patients With Locally Advanced Clear Cell Renal Cell Carcinoma: A Single-Arm, Phase Ii Trial

You have accessJournal of UrologyKidney Cancer: Localized: Surgical Therapy II (PD33)1 May 2024PD33-07 NEOADJUVANT TORIPALIMAB COMBINED WITH AXITINIB IN PATIENTS WITH LOCALLY ADVANCED CLEAR CELL RENAL CELL CARCINOMA: A SINGLE-ARM, PHASE II TRIAL Jiwei Huang Jiwei HuangJiwei Huang View All Author Informationhttps://doi.org/10.1097/01.JU.0001008912.25331.d7.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Combination of axitinib and immune checkpoint inhibitors demonstrated promising efficacy in the treatment of advanced renal cell carcinoma (RCC). However, the efficacy and safety of this combination were less understood in the neoadjuvant context. To prospectively evaluate the safety, efficacy and biomarkers of toripalimab plus axitinib in neoadjuvant setting of non-metastatic clear cell RCC. METHODS: This trial was registered with clinicaltrials.gov (NCT04118855). This is a single-institution, single-arm phase 2 clinical trial. Patients with non-metastatic biopsy-proven clear cell RCC (T2-T3N0-1M0) are enrolled. Patients will receive axitinib 5 mg bid combined with toripalimab 240 mg q3w (3 cycles) for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy. Primary endpoint is Objective Tumor Response Rate (ORR) identified by Response Evaluation Criteria in Solid Tumors. Secondary endpoints include disease-free survival, safety, and perioperative complication rate. Predictive biomarkers are involved in exploratory analysis. RESULTS: A total of 20 patients were enrolled in the study, with 19 of them undergoing surgery. One patient refused surgery. Primary endpoint ORR was 45%. Tumor shrinkage was observed in 95% of patients prior to nephrectomy. Regarding tumor thrombus (TT) response, it was observed that 11 out of 15 patients with TT experienced a volume reduction of ≥40%, despite a moderate change in TT length. Furthermore, four patients achieved a pathological complete response. Grade ≥3 adverse events (AEs) occurred in 25% patients, included hypertension, hyperglycemia, ALT/AST increase, and proteinuria. One patient showed Grade ≥3 postoperative renal insufficiency at 82 days postoperatively. In comparison to patients with stable disease, responders exhibited significant differences in immune factors such as ARG1, MAGEs, DC, TNFSF13, APLNR, and CCL3-L1. The limitation of this trial was small sample size. CONCLUSIONS: Neoadjuvant toripalimab combined with axitinib shows encouraging activity and acceptable toxicity in locally advanced ccRCC and warrants further study. Source of Funding: This work was supported by Shanghai Science and Technology Commission Research Project grant number 21ZR1438900; Basic Oncology Research Program from Bethune Charitable Foundation grant number BCF-NH-ZL-20201119-024; the Incubating Program for Clinical Research and Innovation of Renji Hospital grant number PYIII20-07 and Wu Jieping Medical Foundation grant number 320.6750.2022-19-92 © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e712 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Jiwei Huang More articles by this author Expand All Advertisement PDF downloadLoading ...