The phase 3 RAMPART trial found that adjuvant immunotherapy with durvalumab plus tremelimumab significantly reduced the risk of recurrence in patients with high-risk renal cell carcinoma following surgery.
After a median follow-up of 3.5 years, the combination achieved a 3-year disease-free survival (DFS) rate of 80%, compared with 72% for active monitoring, translating to a 35% reduction in the risk of recurrence or death. Durvalumab alone produced a 3-year DFS rate of 78% but did not meet the study’s predefined threshold for statistical significance. Overall survival remained high across all groups, ranging from 96% to 98%.
The benefit was driven primarily by high-risk patients, who experienced a 48% reduction in recurrence risk and improved 3-year DFS rates of 76% versus 61%.
Grade 3/4 adverse events occurred in 41% of patients receiving combination therapy and 30% receiving durvalumab alone. Despite higher toxicity, quality of life remained generally stable during treatment.