Katy Beckermann, Medical Director of GU Clinical Research at Tennessee Oncology, shared a post on LinkedIn:
”The adjuvant standard in high-risk kidney cancer just changed.
On June 12, 2026, the FDA approved belzutifan plus pembrolizumab for adults with clear cell RCC at intermediate-high or high risk of recurrence after nephrectomy, or after resection of metastatic disease. It’s the first regimen to improve DFS compared to adjuvant pembrolizumab monotherapy in a head-to-head trial.
- LITESPARK-022, phase 3, double-blind, 1,841 patients randomized 1:1
- Clear cell RCC, intermediate-high or high recurrence risk post-nephrectomy, or resected metastases with no evidence of disease
- DFS HR 0.72 (95% CI 0.59-0.87), p=0.0003, a 28% reduction in recurrence or death
- 24-month DFS 80.7% vs 73.7%; median DFS not reached, median follow-up 28.4 months
- More anemia, hypoxia, and liver enzyme elevation with belzutifan
- OS data immature
Why this matters for your practice:
A real DFS gain that supports a new adjuvant option for the highest-risk patients, but the OS readout is still pending and the added toxicity is not trivial. Patient selection and informed decision making.
How are you weighing the DFS benefit against added toxicity for your intermediate-high risk patients while OS matures?
Congrats to Toni Choueiri and the huge team involved in this study!”
Title: Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized phase 3 LITESPARK-022 study.
Authors: Toni K. Choueiri, Robert J. Motzer, Jose A. Karam, Dingwei Ye, Zhisong He, Christian Caglevic, Wesley Yip, Cristina Suárez, Thomas Ferguson, Wayne Yen Hwa Chang, Carlos Rojas, Roberto Iacovelli, Yüksel Ürün, Elena Verzoni, Juan Carlos Vázquez Limón, Camillo Porta, Hong Liu, Manish Sharma, Joseph E. Burgents, Thomas Powles
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