The results from a recent phase II study comparing a combination of dalantercept plus axitinib with axitinib plus placebo for second-line treatment of advanced renal cell carcinoma (RCC) were published in the journal Cancer this month.
The study involved 124 patients with clear cell RCC who had been previously treated with an angiogenesis inhibitor, such as sunitnib or pazopanib. The patients were randomly allocated to be treated with axitinib plus dalantercept (59 patients) or axitinib plus placebo (65 patients).
There was no difference in survival between the two treatment groups and objective response rate was 19.0% in the patients who were given axitinib plus dalantercept and 24.6% among patients receiving axitinib plus placebo. In the patients treated with axitinib plus dalantercept, 59% reported at least one severe (grade 3) adverse event related to the treatment, while 64% of patients receiving axitinib plus placebo reported severe treatment-related adverse events.
The study showed that a combination of axitinib and dalantercept is well tolerated but does not improve survival outcomes in pre-treated patients with advanced clear cell RCC.