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ePoster Display

90P - Longitudinal circulating tumor DNA profiling of metastatic urothelial carcinoma in the POLARIS-03 trial


16 Sep 2021


ePoster Display


Tumour Immunology

Tumour Site

Urothelial Cancer


Haige Chen


Annals of Oncology (2021) 32 (suppl_5): S382-S406. 10.1016/annonc/annonc686


H. Chen1, R. Zhang1, F. Xie2, Y. Zhang2, Y. Wang1, A. Shahatiaili1, J. Zang3, P. Du2, S. Jia2, W. Xue1, G. Zhuang3, Y. Huang1

Author affiliations

  • 1 Department Of Urology, Ren Ji Hospital, School Of Medicine, Shanghai Jiao Tong University, 200127 - Shanghai/CN
  • 2 Ngs Lab, Huidu Shanghai Medical Sciences Ltd, 201499 - Shanghai/CN
  • 3 State Key Laboratory Of Oncogenes And Related Genes, Shanghai Cancer Institute, Ren Ji Hospital, School Of Medicine, Shanghai Jiao Tong University, 200001 - Shanghai/CN


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Abstract 90P


Noninvasive biomarkers for immune checkpoint inhibitors remain a compelling unmet medical need. POLARIS-03 is a multicenter phase II trial to evaluate the safety and efficacy of toripalimab (anti-PD-1) in refractory metastatic urothelial carcinoma (mUC). We assessed the predictive utility of longitudinal circulating tumor DNA (ctDNA) analysis from a single-institution biomarker cohort.


Twenty-seven mUC patients receiving toripalimab (3 mg/kg Q2W) at Ren Ji Hospital were enrolled and consented to Institutional Review Board-approved protocol. Serial plasma specimens were obtained at baseline and then every two cycles during treatment. The 600-gene panel (PredicineATLAS) liquid biopsy assay was applied to probe somatic variants and tumor mutational burden (TMB) by sequencing paired tissue and blood samples. Genomic aberrations were correlated with clinical outcomes.


TMB inferred by ctDNA in blood (bTMB) was in concordance with that measured by matched tumor samples (tTMB). High pretreatment bTMB predicted toripalimab response and correlated with prolonged progression-free survival (Hazard ratio = 0.38, P = 0.07). One patient with an exceptionally high bTMB (60.4 mutations/Mb) and genomic features of microsatellite instability experienced a rapid disease improvement. Early ctDNA clearance identified anti-PD-1 responders. Interestingly, two out of three patients with FGFR3-TACC3 gene fusions achieved partial response. Gene-level alterations in ZFHX3 or CYLD enriched for a clinical benefit.


This study demonstrates the feasibility and effectiveness of bTMB as a potential biomarker for mUC patients undergoing immunotherapy, and supports clinical application of PredicineATLAS liquid biopsy assay as a minimally invasive tool for treatment stratification and therapy monitoring in mUC.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

The authors.


Shanghai Junshi BioSciences; Huidu Shanghai Medical Sciences Ltd.


All authors have declared no conflicts of interest.

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