In this practice-changing study in the CheckMate 274 that evaluated for the first time an adjuvant immunotherapy with nivolumab as compared to placebo in patients with high risk muscle invasive urothelial cancer after radical resection, providing for the first time a newer standard-of-care in the FDA and the EMA approval as nivolumab in this adjuvant setting, of course.
The developmental biomarker body of knowledge is still at its infancy and we are presenting today the data on the first biomarkers that are emerging from this study, looking in particular at the gene expression signature at the tumor mutational burden at the PD1 expression...
In this practice-changing study in the CheckMate 274 that evaluated for the first time an adjuvant immunotherapy with nivolumab as compared to placebo in patients with high risk muscle invasive urothelial cancer after radical resection, providing for the first time a newer standard-of-care in the FDA and the EMA approval as nivolumab in this adjuvant setting, of course.
The developmental biomarker body of knowledge is still at its infancy and we are presenting today the data on the first biomarkers that are emerging from this study, looking in particular at the gene expression signature at the tumor mutational burden at the PD1 expression. So the typical biomarkers have been associated with immunotherapy benefit in patients with advanced urothelial cancer which are linked to the evidence of pre-existing anti-tumor immunity in these patients. The summary of the data basically, is that there was a strong association between interferon gamma gene signature and CD4 gene expression in association with disease free survival. And this association was associated with the nivolumab arm with the treatment effect. So there was a strong predictive value also on the CD4 interferon gamma signature score in relation to the disease-free survival outcomes of these patients.
Additional data we have presented related to the TMB and related to the CD4 point to the role of how these biomarkers has associated with disease-free survival with the weaker evidence of treatment effect according to these biomarkers. So there is of course, a prognostic value and a weaker effect on the predictive value of these biomarkers, but of course, we are still at the beginning and the point is how to best integrate these biomarkers, in particular, to integrate with the PD1 expression in order to see whether we can further improve in the real world, the translation and the selection of patients in real world who may benefit the most from adjuvant nivolumab.