Cabozantinib plus nivolumab and ipilimumab in previously untreated, advanced renal cell carcinoma: final results and biomarker analyses from the phase III COSMIC-313 study - PubMed
11 hours ago
- #immunotherapy
- #biomarkers
- #renal cell carcinoma
- Primary results from COSMIC-313 showed significantly longer progression-free survival (PFS) with first-line cabozantinib plus nivolumab and ipilimumab versus placebo plus nivolumab and ipilimumab in advanced renal-cell carcinoma (RCC).
- Final efficacy and safety results, along with exploratory biomarker analyses, are reported after a median follow-up of 45.0 months.
- Updated median PFS was longer in the cabozantinib (triplet) arm (16.6 months) compared to the placebo (doublet) arm (11.2 months), with no significant difference in median overall survival (OS).
- Grade 3/4 treatment-related adverse events occurred in 75% of patients in the triplet arm and 43% in the doublet arm.
- Patients with higher levels of M2-like macrophages showed significantly improved PFS and OS with the triplet regimen.
- Responders in the triplet arm had elevated angiogenic signatures and reduced immune-related pathways, while responders in the doublet arm exhibited robust immune activation.
- Long-term results confirm a PFS benefit with cabozantinib addition but no OS benefit and no new safety signals.