Pfizer’s JAVELIN Renal 101 study
Pfizer (PFE) and Merck announced in a press release today positive top-line results for their JAVELIN Renal 101 study, which evaluated the combination of Bavencio (avelumab) and Inlyta (axitinib), compared to Sutent (sunitinib), in patients with previously untreated advanced renal cell carcinoma.
The above presentation excerpt shows key details of the study.
About the announcement
Pfizer announced that the interim analysis shows a significant improvement in progression-free survival with the combination, versus sutent monotherapy, in patients with PD-L1 positive advanced renal cell carcinoma. The Independent Data Monitoring Committee confirmed the results.
The alliance also intends to pursue regulatory submissions in the United States, based on interim data from the JAVELIN Renal 101 study. The combination already received a breakthrough therapy designation from the US Food and Drug Administration (or FDA) in December 2017 for advanced renal cell carcinoma.
More about the study
The JAVELIN Renal 101 study includes 886 patients.
The primary endpoints include superiority in prolonging progression-free survival and overall survival in PD-L1 positive advanced renal cell carcinoma.