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Can Belzutifan Improve Adjuvant Therapy?
The phase 3 LITESPARK-022 trial compared adjuvant pembrolizumab plus belzutifan with pembrolizumab plus placebo following resection of clear-cell renal-cell carcinoma.
To evaluate the efficacy and safety of adjuvant pembrolizumab plus belzutifan compared to pembrolizumab plus placebo in patients with surgically resected clear-cell renal-cell carcinoma at increased risk for recurrence.
Approach:
Study Design: A randomized, double-blind, multinational phase 3 trial (LITESPARK-022) involving 1,841 patients.
Intervention: Patients received either 400 mg of intravenous pembrolizumab plus 120 mg of daily oral belzutifan or placebo for up to 1 year.
Endpoints: Primary endpoint was investigator-assessed disease-free survival; secondary endpoints included overall survival and safety.
Key Findings:
Higher disease-free survival was observed in the pembrolizumab plus belzutifan group (92% vs 85% at 12 months, 81% vs 74% at 24 months, and 76% vs 69% at 30 months).
186 patients in the pembrolizumab plus belzutifan group experienced disease recurrence or death compared to 246 in the placebo group.
Grade 3 or higher adverse events occurred in 52% of the belzutifan group versus 30% in the placebo group.
Interpretation:
Adjuvant pembrolizumab plus belzutifan resulted in improved disease-free survival compared to pembrolizumab plus placebo, but overall survival data were immature at the interim analysis.
Limitations:
Small subgroup sample sizes may limit interpretation.
Underrepresentation of Black patients affects generalizability of the findings.
Conclusion:
Adjuvant pembrolizumab plus belzutifan resulted in improved disease-free survival compared to pembrolizumab plus placebo.
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