Data from a recent phase 1b study has shown that a combination of axitinib and pembrolizumab treatment for advanced renal cell carcinoma (RCC) is safe and tolerable, and exhibits promising anti-tumour activity in previously untreated patients. The study data were presented at the 2018 Genitourinary Cancers Symposium held in San Francisco last week.
The researchers hypothesised that combining axitinib, which is a more selective inhibitor of the vascular endothelial growth factor (VEGF) pathway, with pembrolizumab, a programmed death -1 (PD-1) checkpoint inhibitor, would be well tolerated and effective for previously untreated advanced RCC patients. Previous studies looking at combining PD-1 checkpoint inhibitors with VEGF inhibitors have been too toxic for patients, preventing further development.
The study involved 52 previously untreated patients with advanced RCC. The study consisted of a dose-finding phase to determine the maximum tolerated dose, followed by a dose expansion phase to look at efficacy. Median progression-free survival was 20.9 months, and the combination was well tolerated. Overall survival was not reached. A phase 3 trial is underway to compare the combination with sunitinib as a first-line treatment.