Thomas E. Hutson, DO, PharmD, on RCC: Overall Survival Analysis of Lenvatinib, Pembrolizumab, and Sunitinib

Thomas E. Hutson : On behalf of my co-investigators, I presented the final pre-specified overall survival from the Phase 3 CLEAR study with nearly four years follow up. The Phase 3 CLEAR study was an international randomized trial comparing Lenvatinib pembrolizumab, Lenvatinib everolimus versus Sunitinib as first-line therapy for patients with advanced renal cell carcinoma. This data had previously been reported when it met its primary efficacy endpoint, which was improvement in progression-free survival. At that time of that presentation, the secondary endpoints of overall survival and objective response rates were also statistically significant. This resulted in regulatory approval of this regimen and rapid incorporation of this regimen as a major frontline therapy option for patients with advanced RCC throughout the world. This information was also previously published in the New England Journal of Medicine. Now, with additional 23 months follow up, pleased to report that our overall survival is maintained with a hazard ratio of 0.79, and our other efficacy signals such as progression-free survival and response rate remain robust with this longer follow-up. There were also no new additional safety signals. So in conclusion, we're pleased to report with additional nearly four years of follow-up the overall survival progression-free survival and objective response rates remain significant and robust when compared with Sunitinib with no new safety signals of the regimen. And Pembrolizumab and Lenvatinib remain a primary therapy for patients with advanced RCC.