"The overall survival, Kaplan Meier curves, are maintained with a hazard ratio of 0.79 for the intent-to-treat patient population of lenvatinib/pembrolizumab versus sunitinib," said Thomas E. Hutson, DO, PharmD, FACP.
In this video, Thomas E. Hutson, DO, PharmD, FACP, highlights the background and findings of the CLEAR study (NCT02811861). The analysis, “Final prespecified overall survival (OS) analysis of CLEAR: 4-year follow-up of lenvatinib plus pembrolizumab (L+P) vs sunitinib (S) in patients (pts) with advanced renal cell carcinoma (aRCC),” was presented at the 2023 ASCO Annual Meeting in Chicago, Illinois. Hutson is the director of the urologic oncology program at Baylor University Medical Center in Dallas, Texas.
The presentation for ASCO this year is the final prespecified overall survival analysis from the CLEAR study, which was an international randomized trial comparing pembrolizumab/lenvatinib, pembrolizumab/everolimus versus sunitinib as initial therapy in patients with renal cell carcinoma. It had previously been reported to show a statistically significant and clinically meaningful benefit in progression free survival, its primary endpoint, as well as secondary efficacy endpoints of overall survival and response rate. This has been published in the New England Journal of Medicine, and it has resulted in regulatory approval and rapid uptake in the treatment algorithm as a primary therapy for patients with advanced renal cell carcinoma throughout the world.
The current presentation is a prespecified final overall survival analysis occurring after 23 months of additional follow-up, so we're able to address things like duration of benefit. The overall survival, Kaplan Meier curves, are maintained with a hazard ratio of 0.79 for the intent-to-treat patient population of lenvatinib/pembrolizumab versus sunitinib. The secondary efficacy endpoints are also robust and maintained, including progression free survival of 24.3 months for the lenvatinib/pembrolizumab arm and an objective tumor response rate of 71.3% in patients on the lenvatinib/pembrolizumab arm versus sunitinib.
An additional report is looking at long-term or cumulative toxicity. We're pleased to report that there's no additional [adverse] effects with long-term follow-up, no new safety signals, such that we can conclude on our presentation that with final additional follow-up, the overall survival was maintained with robustness, as well as other efficacy endpoints such as response rate, progression free survival. There are no new safety signals, so clinicians should feel very comfortable in using this regimen as a primary treatment strategy for their patients with advanced RCC.
This transcription has been edited for clarity.