Pembrolizumab–Axitinib Improves Survival in Advanced RCC
Brian I. Rini, MD, Professor of Medicine at Lerner College of Medicine, Cleveland Clinic, Ohio, spoke with Oncology Learning Network about the KEYNOTE-426 study, in which pembrolizumab therapy plus axitinib resulted in significantly longer survival than sunitinib in patients with previously untreated, advanced renal-cell carcinoma (RCC; N Engl J Med. 2019;380[12]:1116-1127).
What existing data or circumstances led to the development of the KEYNOTE-426 trial?
VEGF-targeted therapy has been standard in metastatic RCC for many years.
Immuno-oncology agents clearly have activity, and initial trials showed a high response rate and progression-free survival with the combination of such agents, including axitinib and pembrolizumab.
Thus, the phase 3 KEYNOTE-426 study was launched against the standard of care at the time, sunitinib.
Please briefly describe your study and its findings. Were any of the outcomes particularly surprising?
This combination significantly improved overall survival, progression-free survival, and objective response rate vs. sunitinib.
This was the first trial to show improvements in all 3 end points, and the results were the best in terms of improvement over sunitinib that has ever been observed.
Activity of this regimen was expected, but the degree of activity was surprising.
How have these findings been applied to real-world clinical practice?
This regimen is now FDA approved and a standard of care initial therapy for patients with metastatic RCC. I believe it will be widely used.
Do you and your co-investigators intend to expand upon this research?
Yes. Right now we are busy analyzing other aspects of the data (eg, safety, quality-of-life), but soon hope to build upon these results by adding additional agents to this regimen.
