Dr. Hutson on Lenvatinib/Everolimus Combo in RCC

Thomas E. Hutson, DO, PharmD
Published: Saturday, Nov 05, 2016



Thomas E. Hutson, DO, PharmD, director of the Genitourinary Oncology Program, Charles A. Sammons Cancer Center at Baylor University Medical Center, discusses the efficacy associated with the combination of levantinib (Lenvima) and everolimus (Afinitor) in patients with metastatic renal cell carcinoma (RCC).

This combination is very unique, Hutson explains, in that it targets both the VEGF and mTOR pathways. These 2 pathways are believed to be most important in tumor genesis in RCC, and are also 2 pathways where the field already has inhibitors for which have shown efficacy. Additionally, this combination marks the first to be approved in the field of RCC and is the most recent FDA approval for these patients, occurring in May 2016.

The phase II trial, known as Study 205, led to the FDA approval of lenvatinib/everolimus. In the study, patients with clear cell RCC who were treated with 1 prior line of VEGF therapy were randomized to receive lenvatinib plus everolimus versus each drug as single agents, with 50 patients enrolled on each arm. The trial reached its primary endpoint of a statistically significant prolongation in progression-free survival (PFS) compared with the standard of care, single-agent everolimus. The median PFS with the combination was 14.6 months with the combination versus 5.5 months with everolimus.

The trial also achieved its secondary endpoints of response rate—more than 40% tumor shrinkage—and an overall survival benefit. This trial proved a level of activity that places it among the best therapies in the field, Hutson adds.
 

<<< View more from the 2016 International Kidney Cancer Symposium



Thomas E. Hutson, DO, PharmD, director of the Genitourinary Oncology Program, Charles A. Sammons Cancer Center at Baylor University Medical Center, discusses the efficacy associated with the combination of levantinib (Lenvima) and everolimus (Afinitor) in patients with metastatic renal cell carcinoma (RCC).

This combination is very unique, Hutson explains, in that it targets both the VEGF and mTOR pathways. These 2 pathways are believed to be most important in tumor genesis in RCC, and are also 2 pathways where the field already has inhibitors for which have shown efficacy. Additionally, this combination marks the first to be approved in the field of RCC and is the most recent FDA approval for these patients, occurring in May 2016.

The phase II trial, known as Study 205, led to the FDA approval of lenvatinib/everolimus. In the study, patients with clear cell RCC who were treated with 1 prior line of VEGF therapy were randomized to receive lenvatinib plus everolimus versus each drug as single agents, with 50 patients enrolled on each arm. The trial reached its primary endpoint of a statistically significant prolongation in progression-free survival (PFS) compared with the standard of care, single-agent everolimus. The median PFS with the combination was 14.6 months with the combination versus 5.5 months with everolimus.

The trial also achieved its secondary endpoints of response rate—more than 40% tumor shrinkage—and an overall survival benefit. This trial proved a level of activity that places it among the best therapies in the field, Hutson adds.
 

<<< View more from the 2016 International Kidney Cancer Symposium


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