The addition of trebananib to sunitinib may provide a benefit to patients with metastatic clear cell renal cell carcinoma, a new study published online ahead of print in the Journal of Clinical Oncology has shown.

For the phase 2 study, researchers enrolled 85 patients with metastatic renal cell carcinoma and assigned them to receive sunitinib 50 mg orally once daily for 4 weeks on and 2 weeks plus trebananib 10 mg/kg (cohort A) or 15 mg/kg (cohort B) intravenously once weekly.

Efficacy results showed that the objective response rate was 58% in cohort A and 63% in cohort B with a median progression-free survival of 13.9 months (95% CI: 10.4, 19.2) and 16.3 months (95% CI: 13.1, 21.4), respectively.

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Researchers found that median overall survival was 36 months (95% CI: 25.2, not estimable) in cohort A and was not estimable in cohort B at a median follow-up of 25 months.

In regard to safety, the most common adverse events were diarrhea, mucosal inflammation, and hypertension. Grade 3 or greater adverse reactions occurred in 58% and 63% of patients in cohorts A and B, respectively.

During the first 3 months of treatment, 58% of patients in cohort A and 57% of patients in cohort B required sunitinib dose interruptions.

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Trebananib is an investigational recombinant peptide-Fc fusion protein that neutralizes the interaction between the Tie2 receptor and angiopoietin-1/2.

Sunitinib, a kinase inhibitor, is approved under the brand name Sutent for the treatment of patients with advanced renal cell carcinoma at a dose of 50 mg orally once daily for 4 weeks on and 2 weeks off in 6-week cycles.

Preliminary findings were presented at the 48th ASCO Annual Meeting in Chicago, IL, in 2012.


  1. Atkins MB, Gravis G, Drosik K, et al. Trebananib (AMG 386) in combination with sunitinib in patients with metastatic renal cell cancer: an open-label, multicenter, phase II study. J Clin Oncol. 2015. [epub ahead of print]. doi: 10.1200/JCO.2014.60.6012.