Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• Belzutifan demonstrated a significant improvement in progression-free survival (PFS) compared to everolimus. At 18 months, 24.0% of participants in the belzutifan group were alive and free of progression compared to 8.3% in the everolimus group (P = 0.002). However, the median PFS was the same in both groups (5.6 months).
• The overall survival (OS) benefit of belzutifan was not statistically significant, with a median OS of 21.4 months compared to 18.1 months for everolimus (hazard ratio for death, 0.88; 95% CI (Confidence interval), 0.73 to 1.07; P = 0.20).
• The objective response rate (complete or partial response) was significantly higher in the belzutifan group (21.9%, 95% CI, 17.8 to 26.5) compared to the everolimus group (3.5%, 95% CI, 1.9 to 5.9), with P < 0.001 meeting the prespecified significance criterion.
• Grade 3 or higher adverse events occurred in 61.8% of participants in the belzutifan group and 62.5% in the everolimus group, indicating a comparable safety profile between the two treatments. Grade 5 (fatal) adverse events were reported in 3.5% of the belzutifan group and 5.3% of the everolimus group.
• Treatment discontinuation due to adverse events was lower in the belzutifan group (5.9%) compared to the everolimus group (14.7%), suggesting that belzutifan was associated with fewer discontinuations due to adverse effects.
• The study population consisted of individuals with advanced clear-cell renal-cell carcinoma who had previously undergone immune checkpoint and antiangiogenic therapies. Belzutifan showed significant improvements in progression-free survival and objective response in this population, with no new safety concerns reported, demonstrating its safety and efficacy for this specific subgroup of patients.