Nivolumab (Opdivo) may help improve overall survival and with fewer grade 3 or 4 adverse events compared to everolimus (Afinitor) in previously treated advanced renal cell carcinoma, according to new results from the CheckMate 025 phase III clinical trial presented at the 2015 European Cancer Congress in Vienna, Austria, September 25-29, 2015.
Nivolumab (Opdivo) may help improve overall survival and with fewer grade 3 or 4 adverse events compared to everolimus (Afinitor) in previously treated advanced renal cell carcinoma, according to new results from the CheckMate 025 phase III clinical trial presented at the 2015 European Cancer Congress (ECC) in Vienna, Austria, September 25-29, 2015.1
The findings, which were published simultaneously in The New England Journal of Medicine, demonstrated that patients taking nivolumab had a median overall survival of 25 months as compared to 19.6 months for those taking everolimus.2
An immune checkpoint inhibitor drug, nivolumab, blocks the interaction between the programmed cell death protein 1 (PD-1) and programmed cell death protein ligand 1 (PD-L1). However, the survival benefit was seen in patients regardless of the extent of PD-L1 expression in their tumors. “CheckMate 025 is the first and only study in which immunotherapy with an immune checkpoint inhibitor, used after prior treatment has failed, has shown a benefit in overall survival among patients with advanced kidney cancer for whom treatment options are currently limited,” said study investigator Padmanee Sharma, MD, PhD, who is a Professor in the Departments of Genitourinary Medical Oncology and Immunology at the MD Anderson Cancer Center in Houston in a press release.1
Dr. Sharma said the objective response rate was 25% for nivolumab versus 5.4% for everolimus, and the partial response rate was 24.1% for nivolumab versus 4.9% for everolimus. The study also showed that the complete response rate was 1% for nivolumab versus 0.5% for everolimus. “Although we cannot speculate at this time on when nivolumab might enter the clinic, we hope that this study will quickly lead to approval of nivolumab as a standard of care therapy for these patients,” said Dr. Sharma.
The international trial recruited 821 patients with advanced clear cell kidney cancer. All the patients had received prior treatment between October 2012 and March 2014. They were followed up for a minimum of 15 months and the data cut-off point for the analysis presented at ECC 2015 was June 2015, at which point 17% of patients receiving nivolumab and 7% of patients receiving everolimus remained on the treatment. Deaths had occurred among 45% of patients on nivolumab and 54% of patients on everolimus, and the risk of death from any cause was 27% lower among the nivolumab patients, according to the researchers.
The researchers were pleased to see that the grade 3 or 4 treatment-related adverse events occurred in only 19% of the patients receiving nivolumab compared to 37% of the patients receiving everolimus.
The most common treatment-related adverse events among patients who received nivolumab were fatigue (33%), nausea (14%), and pruritus (14%). In contrast, the most common events were fatigue (34%), stomatitis (29%), and anemia (24%) in the patients receiving everolimus. The most common grade 3 or 4 treatment-related adverse events were fatigue, which occurred in 2% of the patients receiving nivolumab and anemia, which occurred 8% of the patients receiving everolimus.