RAMPART Trial: Durvalumab Monotherapy Lacks DFS Benefit in Resected RCC; Combination Shows Benefit in High-Risk Patients

Updated results from the international phase 3 RAMPART trial show that adjuvant durvalumab monotherapy did not provide a significant disease-free survival benefit for patients with resected renal cell carcinoma, while the combination of durvalumab plus tremelimumab demonstrated a benefit concentrated in high-risk patients.

The trial enrolled 790 patients with resected primary renal cell carcinoma. Patients were randomized to receive the combination of the PD-L1 inhibitor durvalumab (Imfinzi) and the CTLA-4 inhibitor tremelimumab (Imjudo), durvalumab monotherapy, or active monitoring. The 3-year disease-free survival rate was 80% in the combination group, 78% in the durvalumab monotherapy group, and 72% in the active monitoring group.

For the combination versus active monitoring, the hazard ratio was 0.65, which was statistically significant. For durvalumab monotherapy versus active monitoring, the hazard ratio was 0.74 with a confidence interval that crossed 1, indicating no statistically significant benefit. When stratified by risk, the benefit from the combination arm appeared to come from patients with high-risk disease (hazard ratio 0.52), while the intermediate-risk population had a non-significant hazard ratio of 1.19.

The findings contrast with historical data for other agents in the adjuvant setting, such as pembrolizumab. Researchers note that while clinical trial data provide a foundation for decision-making, real-world patient factors such as comorbidities, performance status, and overall disease burden often guide treatment selection for renal cell carcinoma. Tolerability, potential toxicities, and patient preferences can also shape regimen selection.