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ESMO 2025 | Identifying biomarkers in first-line mccRCC therapy in the COSMIC 313 trial

Berkay Simsek, MD, Brigham and Women’s Hospital, Boston, MA, explores biomarker analysis from the COSMIC-313 trial (NCT03937219) evaluating first-line nivolumab plus ipilimumab in metastatic clear cell renal cell carcinoma (mccRCC). This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

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Transcript

COSMIC 313 clinical trial is a clinical trial based on metastatic ccRCC comparing the effectiveness of the ipilimumab plus nivolumab versus cabozantinib plus ipilimumab plus nivolumab therapies in these patients and like it is kind of an important clinical trial for the triplet therapies comparing them to the like ipi/nivo which is the standard of care and I am like mainly focusing on the ipilimumab plus nivolumab the pure immunotherapy arm of this like working on the tissue-based biomarkers we have been actually studying like many tissue-based biomarkers on this and mostly studying with the multiplex immune fluorescence and trying to identify the tumor microenvironment elements of the inflammatory cells and the results that I am today like presenting is based on the cytotoxic T cells and we find out that cytotoxic T cells that are expressing PD-1 but not TIM3 or LAG3, which we call as the non-terminal exhausted cytotoxic T cells, they are correlating positively with objective response rate and progression-free survival in these patients in the ipilimumab plus nivolumab arm...

COSMIC 313 clinical trial is a clinical trial based on metastatic ccRCC comparing the effectiveness of the ipilimumab plus nivolumab versus cabozantinib plus ipilimumab plus nivolumab therapies in these patients and like it is kind of an important clinical trial for the triplet therapies comparing them to the like ipi/nivo which is the standard of care and I am like mainly focusing on the ipilimumab plus nivolumab the pure immunotherapy arm of this like working on the tissue-based biomarkers we have been actually studying like many tissue-based biomarkers on this and mostly studying with the multiplex immune fluorescence and trying to identify the tumor microenvironment elements of the inflammatory cells and the results that I am today like presenting is based on the cytotoxic T cells and we find out that cytotoxic T cells that are expressing PD-1 but not TIM3 or LAG3, which we call as the non-terminal exhausted cytotoxic T cells, they are correlating positively with objective response rate and progression-free survival in these patients in the ipilimumab plus nivolumab arm.

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