Brian I. Rini
MD
Professor of Medicine; Chief, Clinical Trials Program
👥Biography 个人简介
Brian I. Rini, MD is Professor of Medicine and Chief of the Clinical Trials Program at Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center. One of the foremost experts in renal cell carcinoma (RCC) in the United States, he has spent two decades advancing the understanding and treatment of kidney cancer through a succession of practice-defining clinical trials. His work has encompassed anti-angiogenic therapy, immunotherapy, and the combination strategies that now define modern first-line RCC management. Dr. Rini is widely recognized as a lead investigator of KEYNOTE-426, the landmark phase III trial demonstrating that the combination of pembrolizumab plus axitinib significantly improved overall survival, progression-free survival, and objective response rate compared with sunitinib in previously untreated advanced clear cell RCC. Published in the New England Journal of Medicine in 2019 and with updated outcomes subsequently reported, KEYNOTE-426 established pembrolizumab plus axitinib as one of the preferred first-line standards and represented a paradigm shift toward immunotherapy-TKI combinations in RCC. Dr. Rini also contributed pivotal research establishing sunitinib and other VEGFR TKIs as first-line standards prior to the immunotherapy era. Beyond KEYNOTE-426, Dr. Rini has led or contributed to numerous phase II and III trials exploring novel TKIs, immunotherapy combinations, and predictive biomarkers in RCC. His translational research addresses mechanisms of resistance to anti-angiogenic therapy, immune evasion in RCC, and biomarker strategies for patient selection. He has authored more than 300 peer-reviewed publications, serves on ASCO and NCCN guideline panels, and is recognized globally as a key architect of current RCC treatment paradigms.
🧪Research Fields 研究领域
🎓Key Contributions 主要贡献
KEYNOTE-426: Pembrolizumab + Axitinib as First-Line RCC Standard
Lead investigator of KEYNOTE-426, the phase III trial demonstrating that pembrolizumab plus axitinib significantly improved overall survival and progression-free survival versus sunitinib in first-line advanced clear cell RCC, leading to FDA approval and establishing this combination as a preferred first-line regimen.
VEGFR Tyrosine Kinase Inhibitor Development in RCC
Contributed to pivotal phase II and III trials evaluating sunitinib, sorafenib, and axitinib in advanced RCC, helping establish VEGFR TKIs as the standard of care in the pre-immunotherapy era and defining the mechanisms of anti-angiogenic activity in kidney cancer.
Axitinib Development and Approval
Principal investigator of AXIS, the phase III trial demonstrating axitinib superiority over sorafenib as second-line RCC therapy, leading to FDA approval of axitinib and informing its later role as the TKI backbone in immunotherapy combination trials.
Predictive Biomarker Research in RCC
Led translational investigations into VEGF pathway biomarkers, immune gene expression signatures, and blood-based markers predictive of response to anti-angiogenic and immunotherapy regimens in RCC, informing patient stratification strategies in both clinical trials and practice.
Representative Works 代表性著作
Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma
New England Journal of Medicine (2019)
Phase III KEYNOTE-426 trial demonstrating significant improvement in overall survival, progression-free survival, and objective response rate with pembrolizumab plus axitinib versus sunitinib in first-line advanced clear cell RCC.
Comparative Effectiveness of Axitinib versus Sorafenib in Advanced Renal Cell Carcinoma (AXIS)
The Lancet (2011)
Phase III AXIS trial demonstrating superior progression-free survival with axitinib versus sorafenib as second-line treatment of advanced RCC, leading to FDA approval of axitinib.
Sunitinib versus Interferon Alfa in Metastatic Renal-Cell Carcinoma
New England Journal of Medicine (2007)
Phase III trial establishing sunitinib as superior to interferon alfa for progression-free survival in first-line metastatic RCC, making sunitinib the first targeted agent approved in this setting.
Atezolizumab plus Bevacizumab versus Sunitinib in Patients with Previously Untreated Metastatic Renal Cell Carcinoma
New England Journal of Medicine (2019)
Phase III IMmotion151 trial evaluating atezolizumab plus bevacizumab versus sunitinib in first-line metastatic RCC, with PFS benefit in PD-L1-positive patients and extensive biomarker analyses.
🏆Awards & Recognition 奖项与荣誉
📄Data Sources 数据来源
Last updated: 2026-04-05 | All information from publicly available academic sources
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