Avelumab Plus Axitinib in Previously Untreated Patients With Advanced Kidney Cancer
The results of the pivotal phase III JAVELIN Renal 101 study—which evaluated avelumab (Bavencio) in combination with axitinib (Inlyta) compared with sunitinib (Sutent) as initial therapy for patients with advanced renal cell carcinoma—were recently announced. As part of a planned interim analysis, an independent data monitoring committee confirmed that the trial showed a statistically significant improvement in progression-free survival by central review for patients treated with the combination whose tumors had programmed cell death ligand 1 (PD-L1) expression greater than 1% (primary objective), as well as in the entire study population regardless of PD-L1 tumor expression (secondary objective). According to the statistical analysis plan, if progression-free survival was statistically significant in the PD-L1–positive subgroup, then progression-free survival in the entire study population was to be analyzed for statistical significance.
JAVELIN Renal 101 will continue as planned to the final analysis for the other primary endpoint of overall survival. No new safety signals were observed, and adverse events for avelumab, axitinib, and sunitinib in this trial were consistent with the known safety profiles of all three aagents. A detailed analysis will also be submitted for presentation at an upcoming medical congress.
In December 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to avelumab in combination with axitinib for treatment-naive patients with advanced renal cell carcinoma.
More on JAVELIN Renal 101
JAVELIN Renal 101 is a global, multicenter, randomized study investigating the efficacy and safety of avelumab in combination with axitinib as a first-line treatment option compared with sunitinib monotherapy in 886 patients with advanced renal cell carcinoma across all risk groups. The primary objectives are to demonstrate that avelumab in combination with axitinib is superior to sunitinib monotherapy in prolonging progression-free or overall survival in patients with PD-L1–positive disease. Avelumab was administered at 10 mg/kg intravenously every 2 weeks in combination with axitinib at 5 mg orally twice daily; sunitinib was administered at 50 mg orally once daily, 4 weeks on/2 weeks off.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
