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.
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.
- 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.