Pembrolizumab Plus Axitinib Versus Sunitinib as First-line Treatment of Advanced Renal Cell Carcinoma: 43-month Follow-up of the Phase 3 KEYNOTE-426 Study
Jazyk angličtina Země Švýcarsko Médium print-electronic
Typ dokumentu časopisecké články, práce podpořená grantem
PubMed
37500340
DOI
10.1016/j.eururo.2023.06.006
PII: S0302-2838(23)02901-9
Knihovny.cz E-zdroje
- Klíčová slova
- Axitinib, Immunotherapy, Pembrolizumab, Renal cell carcinoma, Sunitinib,
- MeSH
- axitinib škodlivé účinky MeSH
- karcinom z renálních buněk * patologie MeSH
- lidé MeSH
- nádory ledvin * patologie MeSH
- následné studie MeSH
- protokoly protinádorové kombinované chemoterapie MeSH
- sunitinib terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Názvy látek
- axitinib MeSH
- pembrolizumab MeSH Prohlížeč
- sunitinib MeSH
Previous analyses of KEYNOTE-426, an open-label, phase 3 randomized study, showed superior efficacy of first-line pembrolizumab plus axitinib to sunitinib in advanced clear cell renal cell carcinoma (ccRCC). We report results of the final protocol-prespecified analysis of KEYNOTE-426. Patients received pembrolizumab 200 mg intravenously every 3 wk plus axitinib 5 mg orally twice daily or sunitinib 50 mg orally once daily (4 wk per 6-wk cycle). The dual primary endpoints were overall survival (OS) and progression-free survival (PFS) as per RECIST v1.1 by a blinded independent central review. The secondary endpoints included objective response rate (ORR) and duration of response (DOR). The median study follow-up was 43 (range, 36-51) mo. Benefit with pembrolizumab plus axitinib versus sunitinib was maintained for OS (hazard ratio [HR], 0.73 [95% confidence interval {CI}, 0.60-0.88]), PFS (HR, 0.68 [95% CI, 0.58-0.80]), and ORR (60% vs 40%). The median DOR was 24 (range, 1.4+ to 43+) versus 15 (range, 2.3-43+) mo in the pembrolizumab plus axitinib versus the sunitinib arm. No new safety signals emerged. These results support pembrolizumab plus axitinib as a standard of care for patients with previously untreated advanced ccRCC. PATIENT SUMMARY: Extended results of KEYNOTE-426 support pembrolizumab plus axitinib as the standard of care for advanced clear cell renal cell carcinoma.
Adelaide and Meath Hospital University College Dublin Belfield Dublin Ireland
Bell Land General Hospital Osaka Japan
Central Clinical Hospital With Outpatient Clinic Moscow Russia
Centre Antoine Lacassagne Université Côte d'Azur Nice France
Centre Hospitalier de l'Université de Montréal Montréal QC Canada
CHU of Québec and Laval University Québec QC Canada
Dnipro State Medical University Dnipro Dnipropetrovsk Oblast Ukraine
Fox Chase Cancer Center Philadelphia PA USA
Georgetown Lombardi Comprehensive Cancer Center Washington DC USA
Merck and Co Inc Rahway NJ USA
Palacký University Medical School and Teaching Hospital Olomouc Czech Republic
Russian Scientific Center of Roentgenology and Radiology Moscow Russia
Sumy Regional Oncology Center Sumy State University Sumy Sumy Oblast Ukraine
Taipei Veterans General Hospital Taipei Taiwan
The Christie NHS Foundation Trust Manchester UK
University Hospital Eberhard Karls University Tübingen Tübingen Germany
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