The approval of immune checkpoint inhibitor combination therapy may be the most significant advance in a decade for the treatment of metastatic renal cell carcinoma, an expert says.
However, the combination of ipilimumab (Yervoy) and nivolumab (Opdivo) is indicated only in previously untreated, intermediate- to poor-risk patients, and is associated with some potentially serious toxicities that signal a need for careful monitoring, according to experts.
For urologists, the most important take-home message right now is that this immune checkpoint inhibitor regimen is effective for advanced kidney cancers with less-than-favorable prognostic risk, according to David F. McDermott, MD, of Dana-Farber/Harvard Cancer Center, Boston.
“Combination immunotherapy is now in the front line for their patients, and for some, remissions are possible,” Dr. McDermott said in an interview with Urology Times. “It's an exciting new option that's going be broadly applied to patients with metastatic untreated kidney cancer.”
The FDA approval was based on data from the CheckMate 214 trial, results of which were recently published in the New England Journal of Medicine (April 5, 2018 [Epub ahead of print]).
That approval is “the most significant advance for the treatment of kidney cancer over the last 10 years,” CheckMate 214 investigator Hans Hammers, MD, PhD, said in a press release issued by UT Southwestern’s Harold C. Simmons Comprehensive Cancer Center, Dallas.
The clinical trial included 1,096 patients were randomized either to the PD-1 inhibitor nivolumab plus the anti-CTLA4 antibody ipilimumab, or to standard treatment with the VEGF tyrosine kinase inhibitor (TKI) sunitinib (Sutent). Investigators reported results according to prognostic group, assessed using criteria developed by the International Metastatic Renal Cell Carcinoma Database Consortium.