KEYNOTE-426 Trial: Pembrolizumab Plus Axitinib Versus Sunitinib in Advanced Kidney Cancer
Posted: Wednesday, April 17, 2019
Pembrolizumab plus axitinib therapy contributed to a 47% lower risk of death and a 31% lower risk of disease progression or death than sunitinib in patients with previously untreated advanced renal cell carcinoma, according to the findings of the phase III KEYNOTE-426 trial, reported by Brian I. Rini, MD, of the Cleveland Clinic Lerner College, Cleveland, and colleagues. They suggest toxic effects of the treatment however require further analysis following their comparative study, which was published in The New England Journal of Medicine.
“The significant overall survival advantage is particularly notable because it has not been achieved with first-line treatment of renal cell carcinoma with the use of anti–VEGF-based therapy administered alone or in combination,” the investigators concluded.
A total of 861 patients were randomly assigned to receive pembrolizumab (200 mg) once every 3 weeks plus axitinib (5 mg) twice daily or sunitinib (50 mg) once daily for the first 4 weeks of each 6-week cycle. A total of 432 patients received the combination therapy, whereas 429 patients received sunitinib.
The percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab-plus-axitinib group and 78.3% in the sunitinib group, with a follow-up of 12.8 months. As for median progression-free survival, it was 15.1 months in those treated with pembrolizumab plus axitinib 11.1 months in those treated with sunitinib. The objective response rate with the combination therapy was 59.3% and with sunitinib, it was 35.7%. Finally, the pembrolizumab-and-axitinib group had a higher rate of adverse events than the sunitinib group (75.8% vs. 70.6%).
“The benefit of pembrolizumab plus axitinib was observed across all [International Metastatic Renal Cell Carcinoma Database Consortium] prognostic risk categories and in both PD-L1 expression subgroups,” Dr. Rini and colleagues concluded.
Disclosure: The study authors’ disclosure information may be found at nejm.org.