The potential oncology treatment, Xtandi (enzalutamide) and leuprolide, was tested among about 1,000 patients with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.
The study compared Xtandi and leuprolide, Xtandi alone and a placebo plus leuprolide, and the research’s primary endpoint was metastasis-free survival. The Xtandi monotherapy reduced the risk of metastasis or death by 37 percent.
For the secondary endpoint, prostate-specific antigen progression, Xtandi plus leuprolide and Xtandi monotherapy reduced the risk, respectively, by 93 percent and 67 percent.
The two companies said they will use the data “to support a potential regulatory submission for Xtandi in this indication in 2023.”
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