Various Targeted Therapies in RCC Coming Down the Pipeline

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There are various emerging targeted therapies in renal cell carcinoma, including cabozantinib, dalantercept plus axitinib.
There are various emerging targeted therapies in renal cell carcinoma, including cabozantinib, dalantercept plus axitinib.

MIAMI – There are various emerging targeted therapies in renal cell carcinoma (RCC), including cabozantinib, dalantercept plus axitinib, tivozanib, and lenvatinib plus everolimus, according to a presentation at the 14th International Kidney Cancer Symposium 2015 (IKCS).1

First, cabozantinib,a tyrosine kinase inhibitor (TKI) of MET and vascular endothelial growth factor receptor (VEGFR)2, was shown to improve median progression-free survival by 3.6 months compared with everolimus (HR, 0.58; 95% CI, 0.45 – 0.75; P < .001) in patients with advanced RCC in a phase 3 trial.

An interim analysis also demonstrated that overall survival with cabozantinib may be better than with everolimus (HR, 0.67; 95% CI, 0.51 – 0.89; P = .005). In regard to safety, grade 3 to 4 diarrhea, fatigue, hand-foot syndrome, and hypertension were more common with cabozantinib than everolimus.

“Cabozantinib is expected to gain FDA approval,” Thomas E. Hutson, DO, PharmD, FACP, of the Genitourinary Oncology at Baylor Sammons Cancer Center in Dallas, TX, said during his presentation.

A phase 2 trial evaluating the combination of investigational dalantercept plus axitinib has also shown promising results thus far. Preliminary results have shown a median progression-free survival of 8.3 months and 12-month progression-free and overall survival rates of 39% and 75%, respectively. Dr. Hutson noted that mature phase 2 will have to be presented.

Another TKI being researched in an upcoming phase 3 trial is tivozanib hydrochloride compared with sorafenib in patients with refractory advanced RCC. Tivozanib was actually rejected by the U.S. Food and Drug Administration in mid-2013 as it failed to show a favorable risk-benefit ratio.

RELATED: High-dose Interleukin-2 Continues To Be Safe, Effective First-Line mRCC Treatment

Tivozanib will now be evaluated for third-line RCC in about 314 patients beginning in the end of 2015 with a planned filing of a New Drug Application in the first half of 2018.

Finally, lenvatinib plus everolimus has also demonstrated a progression-free survival and overall survival benefit compared with everolimus alone. Median progression-free survival was 14.6 months (95% CI, 5.9 – 20.1) with the combination and 5.5 months (95% CI, 3.5 – 7.1) with everolimus (P < .001). Updated median overall survival results show a 10.1-month benefit with lenvatinib plus everolimus compared with everolimus alone (P = .024).

“I get chills down my spine when I think about the benefit coming to patients,” Dr. Hutson concluded.


  1. Hutson TE. Emerging targeted therapies in RCC [Oral presentation at 14th International Kidney Cancer Symposium].

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