Bristol-Myers Squad.

Yet another CheckMate trial adds to the cavalry of promising results for combination immunotherapy, this time as first-line treatment for advanced and/or metastatic renal cell carcinoma (RCC). The phase 3 CheckMate 214 trial assessed combo nivolumab + ipilimumab versus the standard sunitinib (VEGF inhibitor) in >1K RCC patients stratified by PD-L1 expression and IMDC risk. The initial results presented in abstract form at ESMO 2017 report a significant improvement in objective response rate (ORR), which is promising for a disease that has seen few successes in recent months. But is it practice changing..? In a word: no. First, the trial was designed to assess three co-primary endpoints, among which ORR is only one. By design, this trial is negative unless further maturation proves concurrent significant improvements in progression-free survival (PFS) and overall survival (OS). Which brings us to the second point: ORR has intrinsic value only insofar as it indicates meaningful advantages in survival and/or quality of life. So while we commend Bristol-Myers Squibb on another abstract of 60-40 data-disclosures, we'll wait for survival outcomes before calling it a win for the real troops--patients battling RCC.