Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma

This phase 3 trial (KEYNOTE-564) evaluated adjuvant pembrolizumab versus placebo in patients with clear cell renal cell carcinoma at increased risk of recurrence after surgery. With a median follow up of 57.2 months, pembrolizumab significantly improved overall survival (hazard ratio for death, 0.62) and disease free survival (hazard ratio for recurrence or death, 0.72). At 48 months, 91.2% of patients in the pembrolizumab group were alive versus 86.0% in the placebo group. The benefit was consistent across subgroups. Pembrolizumab was associated with higher rates of grade 3–4 adverse events and serious immune related toxicities, but no treatment-related deaths occurred.

This phase 3 trial (KEYNOTE-564) evaluated adjuvant pembrolizumab versus placebo in patients with clear cell renal cell carcinoma at increased risk of recurrence after surgery. With a median follow up of 57.2 months, pembrolizumab significantly improved overall survival (hazard ratio for death, 0.62) and disease free survival (hazard ratio for recurrence or death, 0.72). At 48 months, 91.2% of patients in the pembrolizumab group were alive versus 86.0% in the placebo group. The benefit was consistent across subgroups. Pembrolizumab was associated with higher rates of grade 3–4 adverse events and serious immune related toxicities, but no treatment-related deaths occurred.