Keytruda and Inlyta for renal cell carcinoma – pro
KEYTRUDA® (pembrolizumab) is the first PD-1 inhibitor approved and it was recently indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor(1). Pembrolizumab is able to achieve a dual blockade (PD-L1 and PD-L2r.
In 2014, ASCO presented presented results from a phase 2 trial of a similar drug, nivolumab in renal cell carcinoma (RCC), commonly known as kidney cancer(2). Approximately 20% of a total of 160 patients responded to the treatment, with a 1-year survival rate of about 70%. These results are better than the results of phase 3 trials for the existing drugs approved for the treatment of RCC. A 2019 New England Journal of Medicine article reproted an open-label, phase 3 trial, we randomly assigned 861 patients with previously untreated advanced clear-cell renal-cell carcinoma to receive pembrolizumab (200 mg) intravenously once every 3 weeks plus axitinib (5 mg) orally twice daily (432 patients) or sunitinib (50 mg) orally once daily for the first 4 weeks of each 6-week cycle (429 patients). Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, than treatment with sunitinib. On April 19, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Sharon, Elad, et al. “Immune checkpoints in cancer clinical trials.” Chinese journal of cancer 33.9 (2014): 434-444
Brian I. Rini, M.D. et al, Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma N Engl J Med 2019; 380:1116-1127
NCCN, Kidney Cancer 2019