JAVELIN Renal 101 Trial: Axitinib Plus Avelumab in Kidney Cancer
Posted: Wednesday, March 13, 2019
According to the results of the phase III JAVELIN Renal 101 trial, published in The New England Journal of Medicine, progression-free survival was significantly longer in patients with renal cell carcinoma who were treated with avelumab plus axitinib than with sunitinib. Additionally, the those who received the combination therapy had a higher objective response rate than those who received sunitinib alone, according to Robert J. Motzer, MD, of the Memorial Sloan Kettering Cancer Center, and colleagues.
“Although the efficacy benefit for the combination could be attributed in part to a higher level of activity with axitinib than with sunitinib, the magnitude of benefit with respect to objective response and progression-free survival associated with avelumab plus axitinib as compared with sunitinib supports at least additive if not synergistic effects of the VEGF tyrosine kinase inhibitor–immune checkpoint inhibitor combination,” the authors wrote.
A total of 886 patients with renal cell carcinoma were randomly assigned evenly to receive 10 mg/kg of avelumab every 2 weeks plus 5 mg of axitinib twice daily or 50 mg of sunitinib once daily for 4 weeks. Among the 560 patients with PD-L1–positive tumors, the median progression-free survival was 13.8 months with avelumab plus axitinib compared with 7.2 months with sunitinib. For all patients, progression-free survival was 13.8 moths with avelumab plus axitinib and 8.4 months with sunitinib.
Adverse events during treatment were observed in most patients treated with either therapy (99.5% with avelumab plus axitinib; 99.3% with sunitinib). Grade 3 or higher events were reported in 71.2% and 71.5% of patients in each cohort, respectively.
Disclosure: The study authors’ disclosure information may be found at nejm.org.