Merchan’s Takeaways From the CLEAR Study in Advanced RCC

Jaime Merchan, MD, professor, co-leader of the Translational and Clinical Oncology Research Program and director of the phase 1 clinical trials program at the Sylvester Comprehensive Cancer Center at the University of Miami, discusses what the potential clinical implications or takeaways for colleagues are based on findings from the phase 3 CLEAR study (NCT02811861) in advanced renal cell carcinoma (RCC).

The study is evaluating the treatment of lenvatinib (Lenvima) with pembrolizumab (Keytruda) for treatment of advanced RCC. A biomarker analysis of the CLEAR trial compared 3 treatments for advanced RCC: lenvatinib plus pembrolizumab, lenvatinib plus everolimus, and sunitinib (Sutent).

Findings showed that compared with sunitinib, the lenvatinib and pembrolizumab combination showed superior efficacy in this patient population, regardless of the tested markers, including gene expression signatures related to cell growth, blood vessel formation, and immune response. Specifically, significantly longer rates of progression-free survival (PFS) and overall survival (OS) were observed with lenvatinib plus pembrolizumab.

Transcription:

0:09 | The takeaway from this study is that the combination of lenvatinib and pembrolizumab is an excellent combination that is associated with high response rates, including a good number of complete responses and high median progression-free survival compared with sunitinib. This confirms the value, importance, and relevance of this combination in advanced renal cell carcinoma, regardless of any genomic transcriptomics or biomarker characteristics.

0:46 | There will be further analysis. In my opinion, there needs to be a new type of analysis that may be independent of the classical current gene signatures that are validated in renal cell carcinoma. Hopefully, in the near future, an analysis using different levels of gene expression or different signatures in RCC will be conducted.

REFERENCE:

Motzer RJ, Porta C, Eto M, et al. Biomarker analyses in patients with advanced renal cell carcinoma (aRCC) from the phase 3 CLEAR trial. J Clin Oncol. 2024;42(suppl 16):4504. doi:10.1200/JCO.2024.42.16_suppl.4504