Ivonescimab治疗既往接受过免疫检查点阻断治疗的晚期透明细胞肾细胞癌患者的II期试验：IVORY试验（NCT06940518）.pdf

1、Phase II trial of ivonescimab in previously treated patients with advanced clear cell renal cell carcinoma(IVORY)Nazli Dizman,MDUniversity of Texas MD Anderson Cancer CenterNCT06940518Introduction/Mechanism Ivonescimab is a novel first-in-class bispecific antibody simultaneously blocking PD-1 and VE

2、GF Enables spatial proximity of concurrent PD-1 and VEGF inhibition within the tumor microenvironment:cooperative inhibition Integrated,synchronized inhibition of two key pathways potentially to address tumor heterogeneity Avoids pharmacokinetic variability and provide more predictable dosing and dr

3、ug levels(T1/2 of 6-7d),improving efficacy,reducing the risk of suboptimal therapeutic exposure,and providing a favorable safety profileZhong T,et al.Mol Cancer Ther(2023)22(12_Supplement):B123.NazliDizmanTrial DesignICI:Immune checkpoint inhibitor,mRCC:Metastatic renal cell carcinoma,VEGF-TKI:Vascu

4、lar endothelial growth factor tyrosine kinase inhibitor,SOC:Standard of Care.TOP designCohort 10:ORR=10%and DCR=30%1:ORR=30%and DCR=50%Acceptable if:4 objective responses or 9 disease controls calibrated for multiplicity=82%,power 96%=20%(1-tailed)Cohort 20:ORR=5%and DCR=20%1:ORR=20%and DCR=40%Accep

5、table if:3 Objective responses or 7 disease controls calibrated for multiplicity=84%,power 91%=12.5%(1-tailed)NazliDizmanVision/Impact This is the first clinical trial of a PD(L)1 x VEGF bispecific in renal cell carcinoma.Potential clinical activity signals and translational insights obtained through this trial will Shape the understanding of approaches to revert ICI-resistance in RCC Open venues for further clinical testing of this agent in mccRCC.NCT06940518 NazliDizman