A new combination of vorolanib, a tyrosine kinase inhibitor plus everolimus, an mTOR inhibitor shows promise for the treatment of advanced renal cell carcinoma (RCC). A phase 1 study looking at how well the combination is tolerated by patients, safety (side effects), and how the combination works in the body, has shown some promise.
Twenty-two patients with advanced RCC that was not responding to treatment were enrolled in the study. Increasing doses of the combination were given in 28-day cycles until the cancer progressed or the patient could not tolerate the dose.
Only one patient could not tolerate the dose and the most common treatment-related adverse events were increased protein in the urine (proteinuria, 100%), low levels of white blood cells (leukopenia, 77%), high cholesterol (77%), fats (64-68%), and sugars (hyperglycaemia, 59%) in the blood, and fatigue (55%).
Effectiveness of the vorolanib/everolimus combination was evaluable in 19 patients; the overall response rate was 32% and disease control rate was 100%.
In conclusion, combination therapy of vorolanib 200 mg plus everolimus 5 mg once daily is potentially an effective treatment for advanced RCC and further evaluation of the combination is ongoing.