Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial

摘要: Summary Background The first interim analysis of the KEYNOTE-426 study showed superior efficacy pembrolizumab plus axitinib over sunitinib monotherapy in treatment-naive, advanced renal cell carcinoma. exploratory with extended follow-up reported here aims to assess long-term and safety versus patients Methods In ongoing, randomised, open-label, phase 3 study, adults (≥18 years old) carcinoma clear histology were enrolled 129 sites (hospitals cancer centres) across 16 countries. Patients randomly assigned (1:1) receive 200 mg intravenously every weeks for up 35 cycles 5 orally twice daily or 50 once 4 per 6-week cycle. Randomisation was done using an interactive voice response system integrated web system, stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk status geographical region. Primary endpoints overall survival progression-free intention-to-treat population. Since primary met at analysis, updated data are nominal p values. This is registered ClinicalTrials.gov, NCT02853331. Findings Between Oct 24, 2016, Jan 2018, 861 (n=432) (n=429). With a median 30·6 months (IQR 27·2–34·2), continued clinical benefit observed terms (median not reached vs 35·7 [95% CI 33·3–not reached] sunitinib); hazard ratio [HR] 0·68 0·55–0·85], p=0·0003) 15·4 [12·7–18·9] 11·1 [9·1–12·5]; 0·71 [0·60–0·84], Interpretation follow-up, results from show that continues have outcomes sunitinib. These continue support first-line treatment as standard care Funding Merck Sharp & Dohme Corp, subsidiary Co, Inc.