This combination [lenvatinib and everolimus] is a potential game-changer in metastatic renal cell carcinoma. We’ve studied other combinations to no avail; for example, bevacizumab [Avastin] plus everolimus had no advantage over everolimus alone. Other combinations are too toxic, such as sunitinib plus bevacizumab. These results are potentially exciting. We have no other approved combinations in metastatic renal cell carcinoma,” said Sumanta K. Pal, MD, Researcher and Co-Director, Kidney Cancer Program, City of Hope, Duarte, California.

“Typically, we expect progression-free survival of around 5 months, and the combination achieved median progression-free survival approaching 15 months. These are encouraging results and the best margin of improvement we have seen within the confines of a randomized controlled trial in pretreated patients,” he added.

The toxicities need to be better characterized, he continued, but they are acceptable for moving to a phase III trial. A phase III trial is being considered, but the design is yet undetermined.

Dr. Pal commented that with this combination, as with all new drugs in oncology, it is important to determine the relevant targets and identify biomarkers to establish which groups of patients will preferentially benefit. ■

Disclosure: Dr. Pal has received consulting fees from Pfizer, Novartis, and Genentech.