Pembrolizumab plus lenvatinib with belzutifan or quavonlimab as first-line therapy for advanced renal-cell carcinoma: randomized open-label phase 3 LITESPARK-012 study.

Adding belzutifan or quavonlimab to pembrolizumab plus lenvatinib in previously untreated advanced clear-cell renal-cell carcinoma did not improve PFS or OS.

• Why it matters: The study addressed whether targeting HIF-2α or CTLA-4 could enhance first-line outcomes beyond pembrolizumab plus lenvatinib, which is already standard care.
• What they did: In LITESPARK-012, 560 participants received pembrolizumab 400 mg Q6W plus lenvatinib 20 mg daily plus belzutifan 120 mg daily, 562 received MK-1308A (25 mg/400 mg) Q6W plus lenvatinib, and 566 received pembrolizumab plus lenvatinib; PFS and OS were dual primary endpoints.
• The result: Median PFS was 20.8 months (HR 1.08, P=0.8408) with belzutifan and 20.7 months (HR 1.07, P=0.8174) with quavonlimab versus 23.7 months in control, with OS not improved; discontinuations from adverse events were 51.6% and 51.4% versus 36.2%.

AI summary of the abstract · may contain errors · not medical advice · read the paper.