The European Medicines Agency (EMA) will review Bristol-Myers Squibb’s application seeking to expand the indications for Opdivo (nivolumab) plus Yervoy (ipilimumab) to include intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC).
“Renal cell carcinoma accounts for more than 100,000 deaths worldwide each year, and for untreated patients who have an advanced form of the disease, there are few treatment options available in the European Union,” Murdo Gordon, executive vice president and chief commercial officer of Bristol-Myers Squibb, said in a press release. “The validation of this application for the Opdivo plus Yervoy combination attests to our commitment to bring Immuno-Oncology treatment to as many patients as possible, especially those with a great unmet need, including patients with RCC.”
The application is based on results from the CheckMate-214 Phase 3 study (NCT02231749), which investigated the effects of Opdivo plus Yervoy in untreated patients with advanced or metastatic RCC.
The trial included 1,096 patients who were randomly assigned Opdivo plus Yervoy or Pfizer’s Sutent (sunitinib), an FDA-approved medicine for the treatment of renal cell carcinoma.
Those in the combination group received four doses of the immunotherapies, given intravenously every three weeks, followed by Opdivo every two weeks. Sutent was given daily for four weeks, followed by two weeks off, in six-week cycles.
The trial’s main goals were to determine if the combination led to better overall survival and response rates, and whether it delayed disease progression in patients with intermediate or poor-risk disease, compared to Sutent.
While the study met the primary outcomes of overall survival and objective response rate, it failed to reach statistical significance in the time to disease progression. But a tendency toward delayed progression was seen.
The findings were recently presented during the ESMO 2017 Congress in a presentation titled, “CheckMate 214: Efficacy and safety of nivolumab + ipilimumab (N+I) v sunitinib (S) for treatment-naïve advanced or metastatic renal cell carcinoma (mRCC), including IMDC risk and PD-L1 expression subgroups.”
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that enhances the body’s natural immune responses against tumors.
Yervoy is also an immune checkpoint inhibitor, but it targets the protein receptor CTLA-4, known for its role in shutting down the immune system.