A clinical trial looking at the combination of avelumab plus axitinib for renal cell carcinoma (RCC), JAVELIN Renal 101, has released some positive top-line results, which will be presented at an upcoming medical congress.
JAVELIN Renal 101 is a pivotal phase III study with 886 renal cancer patients. As part of a planned interim analysis, an independent Data Monitoring Committee confirmed a “statistically significant improvement” in progression-free survival (PFS) in patients treated with the avelumab plus axitinib combination compared to patients treated with sunitinib in the first-line.
The avelumab plus axitinib combination was granted Breakthrough Therapy Designation by the FDA in December 2017, and the manufacturers intend to pursue an FDA submission based on these interim results. Breakthrough Therapy Designation speeds up the development of drugs for serious or life-threatening conditions that are shown to demonstrate substantial improvement over existing treatments.