Belzutifan-Pembrolizumab DFS Benefit Fades After Treatment Ends in Renal Cell Carcinoma
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A reconstructed individual patient data analysis of ten phase 3 adjuvant renal cell carcinoma trials, posted on medRxiv on October 16, 2026, examines whether the disease-free survival benefit of adding belzutifan to adjuvant pembrolizumab in LITESPARK-022 persists beyond the planned treatment period. The analysis finds the benefit attenuates after treatment ends: the hazard ratio was 0.55 (0.43-0.71) before month 12 but 1.16 (0.87-1.54) afterwards, a post/pre ratio of 2.10. This pattern matches trials whose benefit faded, such as SORCE and PROTECT, rather than KEYNOTE-564, where it persisted. The 24-month restricted mean survival time difference was 1.34 months (0.73-1.95). The durability of the absolute advantage remains uncertain, and the authors advise against single-hazard-ratio projections.
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- medrxiv.orgDoes the Disease-free Survival Benefit of Adding Belzutifan to Adjuvant Pembrolizumab Persist Beyond the Planned Treatment Period? A Reconstructed Individual Patient Data Analysis of Phase 3 Renal Cell Carcinoma Trials
The DFS benefit of adding belzutifan to adjuvant pembrolizumab in LITESPARK-022 attenuates after treatment ends, a reconstructed individual patient data analysis of ten phase 3 adjuvant renal cell carcinoma trials finds. The hazard ratio was 0.55 (0.43-0.71) before month 12 but 1.16 (0.87-1.54) afterwards, a post/pre ratio of 2.10, matching trials whose benefit faded (SORCE, PROTECT) rather than KEYNOTE-564, where it persisted. The 24-month restricted mean survival time difference was 1.34 months (0.73-1.95), and durability of the absolute advantage is uncertain, so single-HR projections should be avoided.
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