1、Integrative clinical,genomic,transcriptomic,and immunopathologic characterizationof circulating KIM-1 in metastatic RCCMarc Machaalani1,Renee-Maria Saliby2,Caiwei Zhong1,Eddy Saad1,Clara Steiner1,Emre Yekeduz1,Liliana Ascione1,Mustafa Saleh1,Jad El Masri1,Pablo Moura Barrios1,Xiaowen Liu3,Ti Cai4,Ma
2、xine Sun1,Gwo-Shu Mary Lee1,Wanling Xie1,Sabina Signoretti5,David F.McDermott3,Toni K.Choueiri1,Wenxin Xu1.1 Dana-Farber Cancer Institute,Boston,MA.2 Yale School of Medicine,New Haven,CT.3 Beth Israel Deaconess Medical Center,Boston,MA.4 EMD Serono,Billerica,MA.5 Brigham and Womens Hospital,Boston,M
3、A.BackgroundKIM-1 is a transmembrane protein that isover-expressed in RCC and its ectodomain circulates in plasma1.The JAVELIN Renal 101 trial established avelumab and axitinib as a standard treatment regimen for metastatic RCC2.1.Han WK et al.J Am Soc Nephrol.2005 Apr;16(4):1126-34.2.Motzer RJ et a
4、l.N Engl J Med.2019 Mar 21;380(12):1103-1115.AimEvaluate the association between plasma KIM-1 levels and clinical outcomes and the underlying biologyin patients with mRCC from JAVELIN Renal 101JAVELIN Renal 101EXCLUSIO ZONEChoueiri TK et al.Ann Onc.2024.PMID:39706335Primary Endpoint:PFS or OS in pat
5、ients with PD-L1+tumorsOS:Not SignificantHR:0.86(95%CI 0.701-1.057);one-sided P=0.0755 mPFS in Overall Population13.9 vs 8.5 mos(A+A vs Sun)mOS in PD-L1+Population43.2 vs 36.2 mos (A+A vs Sun)Study DesignBaseline Characteristics VariableAvelumab plus Axitinib(n=323)Number of patients(%)or Median(IQR
6、)Sunitinib(n=289)Number of patients(%)or Median(IQR)Age,years61(5567)61(5468)SexMale239(74)217(75)Female84(26)72(25)ECOG Performance Status0215(67)192(66)1108(33)97(34)IMDC Risk GroupFavorable69(21)68(24)Intermediate197(61)180(62)Poor54(17)40(14)Not available3(1)1(0)KIM-1,pg/mL330(901,479)395(941,52