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Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: final analysis of efficacy and safety from the phase III CheckMate 214 trial - PubMed

3 days ago
  • #immunotherapy
  • #renal cell carcinoma
  • #clinical trial
  • Nivolumab plus ipilimumab (NIVO+IPI) showed significant long-term survival benefits in advanced renal cell carcinoma (aRCC) compared to sunitinib (SUN).
  • Final analysis from the phase III CheckMate 214 trial with 9.3 years median follow-up demonstrated improved overall survival (OS) and progression-free survival (PFS) for NIVO+IPI.
  • Hazard ratios (HR) for OS favored NIVO+IPI over SUN: 0.71 (intention-to-treat), 0.69 (intermediate/poor-risk), and 0.80 (favorable-risk).
  • 108-month OS probabilities were higher with NIVO+IPI (31.4%) versus SUN (19.5%) in intention-to-treat patients.
  • PFS probabilities at 96 months were 22.7% (NIVO+IPI) versus 9.0% (SUN) in intention-to-treat patients.
  • Durable responses were observed, with 48.0% of NIVO+IPI patients remaining in response at 96 months versus 19.0% for SUN.
  • Grade 3-4 treatment-related adverse events were lower with NIVO+IPI (48.6%) compared to SUN (64.1%).
  • NIVO+IPI remains a first-line standard of care for aRCC due to its substantial survival benefit and manageable safety profile.