Opdivo for renal cell carcinoma – pro
In a randomized phase II trial reported in the Journal of Clinical Oncology, Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues found that the programmed cell death protein-1 (PD-1) immune checkpoint inhibitor antibody nivolumab (Opdivo) was associated with antitumor activity and manageable toxicity at three dose levels in patients with metastatic renal cell carcinoma who had previously received vascular endothelial growth factor (VEGF) inhibitor therapy.
The investigators concluded:
“Nivolumab demonstrated antitumor activity with a manageable safety profile across the three doses studied in [metastatic renal cell carcinoma]. No dose-response relationship was detected as measured by [progression-free survival]. These efficacy and safety results in [metastatic renal cell carcinoma] support study in the phase III setting.”
A phase III trial comparing nivolumab and everolimus in patients with metastatic renal cell carcinoma previously treated with antiangiogenic therapy and a phase III trial evaluating the combination of nivolumab and ipilimumab (Yervoy) in first-line treatment of metastatic renal cell carcinoma was recently completed. Checkmate 25 study was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm of everolimus.
1.Robert J. Motzer, Brian I. Rini, David F. McDermott, Bruce G. Redman, Timothy M. KuzNivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial.
./Motzer RJ, Rini BI, McDermott DF, et al. Nivolumab for metastatic renal cell carcinoma: results of a randomized phase II trial. J Clin Oncol. 2015;33(13):1430-1437. JCO December 1, 2014
3. B. Escudier, T. Eisen, C. Porta, J. J. Patard, V. Khoo, F. Algaba, P. Mulders, V. Kataja,,Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.Ann Oncol (2012) 23 (suppl 7): vii65-vii71