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    Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma

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    Authors
    Rini, I
    Plimack, R
    Stus, V
    Gafanov, R
    Hawkins, Robert E
    Nosov, D
    Pouliot, F
    Alekseev, B
    Soulieres, D
    Melichar, B
    Vynnychenko, I
    Kryzhanivska, A
    Bondarenko, I
    Azevedo, SJ
    Borchiellini, D
    Szczylik, C
    Markus, M
    McDermott, S
    Bedke, J
    Tartas, S
    Chang, H
    Tamada, S
    Shou, Q
    Perini, F
    Chen, M
    Atkins, B
    Powles, T
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    Affiliation
    Cleveland Clinic Taussig Cancer Institute, Cleveland
    Issue Date
    2019
    
    Metadata
    Show full item record
    Abstract
    BACKGROUND: The combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renal-cell carcinoma. Whether pembrolizumab plus axitinib would result in better outcomes than sunitinib in such patients was unclear. METHODS: In an open-label, phase 3 trial, we randomly assigned 861 patients with previously untreated advanced clear-cell renal-cell carcinoma to receive pembrolizumab (200 mg) intravenously once every 3 weeks plus axitinib (5 mg) orally twice daily (432 patients) or sunitinib (50 mg) orally once daily for the first 4 weeks of each 6-week cycle (429 patients). The primary end points were overall survival and progression-free survival in the intention-to-treat population. The key secondary end point was the objective response rate. All reported results are from the protocol-specified first interim analysis. RESULTS: After a median follow-up of 12.8 months, the estimated percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab-axitinib group and 78.3% in the sunitinib group (hazard ratio for death, 0.53; 95% confidence interval [CI], 0.38 to 0.74; P<0.0001). Median progression-free survival was 15.1 months in the pembrolizumab-axitinib group and 11.1 months in the sunitinib group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.57 to 0.84; P<0.001). The objective response rate was 59.3% (95% CI, 54.5 to 63.9) in the pembrolizumab-axitinib group and 35.7% (95% CI, 31.1 to 40.4) in the sunitinib group (P<0.001). The benefit of pembrolizumab plus axitinib was observed across the International Metastatic Renal Cell Carcinoma Database Consortium risk groups (i.e., favorable, intermediate, and poor risk) and regardless of programmed death ligand 1 expression. Grade 3 or higher adverse events of any cause occurred in 75.8% of patients in the pembrolizumab-axitinib group and in 70.6% in the sunitinib group. CONCLUSIONS: Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, than treatment with sunitinib. (Funded by Merck Sharp & Dohme; KEYNOTE-426 ClinicalTrials.gov number, NCT02853331.).
    Citation
    Rini B, Plimack E, Stus V, Gafanov R, Hawkins R, Nosov D, et al. Pembrolizumab plus axitinib versus sunitinib for advanced renal-cell carcinoma. N Engl J Med. 2019.
    Journal
    New England Journal of Medicine
    URI
    http://hdl.handle.net/10541/621708
    DOI
    10.1056/NEJMoa1816714
    PubMed ID
    30779529
    Additional Links
    https://dx.doi.org/10.1056/NEJMoa1816714
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1056/NEJMoa1816714
    Scopus Count
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