Cabozantinib plus nivolumab and ipilimumab in previously untreated, advanced renal cell carcinoma: final results and biomarker analyses from the phase III COSMIC-313 study
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Le résumé fourni par la source
BACKGROUND: Primary results from COSMIC-313 demonstrated significantly longer progression-free survival (PFS) with first-line cabozantinib plus nivolumab and ipilimumab versus placebo plus nivolumab and ipilimumab in patients with advanced renal cell carcinoma. Final efficacy and safety results, as well as data from exploratory biomarker analyses, are reported here. PATIENTS AND METHODS: The design, participants, and primary-endpoint PFS outcomes have been reported previously for this phase III, double-blind, randomized (1 : 1) study of cabozantinib or placebo plus nivolumab and ipilimumab in adults with previously untreated, advanced clear cell renal cell carcinoma. The secondary endpoint was overall survival (OS) in the intention-to-treat population. Exploratory biomarker analyses investigated the potential association between immune cell types and gene signatures with clinical outcomes. RESULTS: After a median follow-up of 45.0 months, the updated median PFS in the cabozantinib (triplet) arm was longer than in the placebo (doublet) arm (16.6 versus 11.2 months; hazard ratio 0.82, 95% confidence interval 0.69-0.98). There was no significant difference in median OS (hazard ratio 1.02, 95% confidence interval 0.85-1.23, P = 0.84), and the safety profile was consistent with the earlier analysis (grade 3/4 treatment-related adverse events occurred in 75% and 43% of patients in the triplet and doublet arms, respectively). In patients with higher levels of M2-like macrophages, the triplet regimen was associated with significantly improved PFS and OS compared with the doublet regimen. Responders in the triplet arm exhibited elevated angiogenic signatures and reduced immune-related pathways, while responders in the doublet arm had robust immune activation. CONCLUSIONS: Long-term results from COSMIC-313 continue to demonstrate a PFS benefit with the addition of cabozantinib to nivolumab and ipilimumab. There was no OS benefit and no new safety signals were observed. Exploratory biomarker analyses suggest adding cabozantinib to nivolumab and ipilimumab improves survival in patients with high levels of M2-like macrophages.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Cabozantinib plus nivolumab and ipilimumab in previously untreated, advanced renal cell carcinoma: final results and biomarker analyses from the phase III COSMIC-313 study
- Date Crossref
- 01/06/2026
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Memorial Sloan Kettering Cancer Center pays non établi dans la noticeÉtablissement de santé
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Université Paris-Saclay Institut Gustave Roussy pays non établi dans la noticeUniversité ou école supérieure
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Institut Gustave Roussy pays non établi dans la noticeStructure de recherche
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Tecnológico de Monterrey pays non établi dans la noticeUniversité ou école supérieure
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National Cancer Centre Singapore pays non établi dans la noticeÉtablissement de santé
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Górnośląskie Centrum Medyczne pays non établi dans la noticeÉtablissement de santé
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Washington University in St. Louis pays non établi dans la noticeUniversité ou école supérieure
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Instituto Alexander Fleming pays non établi dans la noticeÉtablissement de santé
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Institut Claudius Regaud pays non établi dans la noticeÉtablissement de santé
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Istituti Clinici Scientifici Maugeri Translational Oncology Unit pays non établi dans la noticeÉtablissement de santé
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Hospital Universitario Central de Asturias Medical Oncology Department pays non établi dans la noticeÉtablissement de santé
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Hospital General Universitario Gregorio Marañón Medical Oncology Department pays non établi dans la noticeÉtablissement de santé
Memorial Sloan Kettering Cancer Center, Institut Gustave Roussy — Université Paris-Saclay et Institut Gustave Roussy, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.