短期强化帕博利珠单抗（KEytruda）和替沃扎尼治疗高危肾细胞癌——STRIKE！（A033201）——（NCT06661720）.pdf

1、Short TeRm Intensified Pembrolizumab(KEytruda)and Tivozanib for High-risk renal cell carcinoma-STRIKE!(AO32201)Bradley A McGregor,MDMarra Lochiatto Investigatorship in Kidney CancerDana Farber Cancer Institute,Boston MAOn behalf of STRIKE!TeamUpdated Survival for KN564Haas,et al ASCO 2025How can we

2、do better?TivozanibTivozanib PK is unaltered by the addition of NivolumabTumor Size Reduction Models Revealed a Significant Relationship with Tivo Exposure:Higher Exposure,Greater Tumor EffectCheck out our Poster!R1:1Key Eligibility Criteria ccRCC pT2,grade 4 pT3 any grade TxN1 M1 NED within year of

3、 nephrectomy(ablative therapy allowed)No prior systemic therapy for RCC ECOG PS 0-1 N=1040+Tivozanib 1.34 mg D1-21 q28D for 6 months*PembrolizumabFor 12 monthsPembrolizumab For 12 months*Reductions to 0.89 D1-21,0.89 mg every other day;no limits on dose interruptionsPrimary Endpoint DFSKey Secondary

4、 Endpoint-OSSecondary Endpoints QOL,Toxicities,Biomarkers+Stratify by T2/T3,T4/N1 or M1NED+A032201/NCT06661720Principles of Adjuvant therapyPresence of residual diseaseHost capable of responding to therapyTumor capable of responding to therapyDeterminants of effective adjuvant therapyAdapted from Br

5、aunSLIDE DIMENSIONS SHOULD FOLLOW 16:9 RATIO1)Which patients needs adjuvant therapy?-MRD Assays and change with therapy(2 STRECT tubes)-Methylated tumor DNA and other novel targets-Digital pathology and radiomics2)Is tumor capable of responding to therapies?Which therapy is needed?-Exploratory analy

6、sis of the tumor genetic alterations and transcriptomic signatures predictive of benefit to adjuvant pembrolizumab,tivozanib3)Is host capable of responding to therapies?-Baseline cytokines and changes on therapy(2 EDTA Tubes)NephrectomyRadi