Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Inlyta® (axitinib), a tyrosine kinase inhibitor, for first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA® in combination with axitinib (KEYTRUDA®-axitinib combination) compared to sunitinib. For Canadians living with advanced renal cell carcinoma, the cancer has spread beyond the kidney to other areas of the body. While the five-year survival rate for patients living with Stage 1 RCC is currently estimated to be 81%, those living with advanced (Stage 4) RCC face an 8% chance of survival. In the Phase 3 KEYNOTE-426 trial, KEYTRUDA® in combination with axitinib demonstrated a statistically significant reduced risk of death by 47% compared to sunitinib (HR=0.53 [95% CI, 0.38-0.74]; p=0.00005). For progression-free survival (PFS), the KEYTRUDA®-axitinib combination showed a reduction in the risk of progression of disease or death of 31% compared to sunitinib (HR=0.69 [95% CI, 0.57-0.84]; p=0.00012). The objective response rate (ORR), an additional efficacy outcome measure, was 59% for patients who received the KEYTRUDA®-axitinib combination (95% CI, 54-64) and 36% for those who received sunitinib (95% CI, 31-40) (p<0.0001). The observed safety profiles of pembrolizumab plus axitinib were as expected on the basis of the known profiles of these drugs, although the incidence of grade 3 or 4 elevations in liver enzyme levels in the pembrolizumab-axitinib group was higher than previously observed when each agent was used as monotherapy. This is the first indication for KEYTRUDA® in advanced RCC, and the first anti-PD-1 therapy as part of a combination regimen that significantly improved OS, PFS and ORR versus sunitinib in patients with advanced RCC.