Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma.
Publication/Presentation Date
3-21-2019
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
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.).
Volume
380
Issue
12
First Page
1116
Last Page
1127
ISSN
1533-4406
Published In/Presented At
Rini, B. I., Plimack, E. R., Stus, V., Gafanov, R., Hawkins, R., Nosov, D., Pouliot, F., Alekseev, B., Soulières, D., Melichar, B., Vynnychenko, I., Kryzhanivska, A., Bondarenko, I., Azevedo, S. J., Borchiellini, D., Szczylik, C., Markus, M., McDermott, R. S., Bedke, J., Tartas, S., … KEYNOTE-426 Investigators (2019). Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. The New England journal of medicine, 380(12), 1116–1127. https://doi.org/10.1056/NEJMoa1816714
Disciplines
Medicine and Health Sciences
PubMedID
30779529
Department(s)
Hematology-Medical Oncology Division, Lehigh Valley Topper Cancer Institute
Document Type
Article