Enzalutamide regimen prolongs metastasis-free survival in nonmetastatic prostate cancer
A combination of enzalutamide and leuprolide significantly extended metastasis-free survival for men with nonmetastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence, according to a company press release.
Results of the randomized phase 3 EMBARK trial also showed a statistically significant and clinically meaningful improvement of metastasis-free survival (MFS) among men who received enzalutamide (Xtandi; Astellas, Pfizer) monotherapy vs. placebo and leuprolide, the companies announced.
The double-blind, three-arm trial enrolled 1,068 men randomly assigned to 160 mg daily enzalutamide, an androgen receptor signaling inhibitor, as monotherapy or with leuprolide, or leuprolide and placebo.
MFS for enzalutamide plus leuprolide and placebo plus leuprolide served as the primary endpoint. The study achieved this endpoint, with a statistically significant and clinically meaningful improvement in MFS with the enzalutamide vs. leuprolide regimen, according to the release.
The analysis also showed a positive trend in OS, a key secondary endpoint, but data remained immature. Other key secondary endpoints that reached statistical significance included time to PSA progression and time to first use of new antineoplastic therapy.
Researchers observed no new safety signals with enzalutamide in the preliminary safety analysis, with is consistent with the agent’s established safety profile.
“While current treatment options for localized prostate cancer are intended to be curative, some men remain at higher risk for biochemical recurrence following primary treatment, which may result in metastases,” Ahsan Arozullah, MD, MPH, senior vice president and head of development therapeutic areas for Astellas, said in the press release. “The EMBARK trial is the first study to demonstrate a statistically significant improvement in MFS using the combination of Xtandi plus leuprolide in men with this stage of disease.”
Enzalutamide is approved in the U.S. for men with metastatic hormone-sensitive prostate cancer and metastatic and nonmetastatic castration-resistant prostate cancer. The EMBARK trial data will be presented at future medical conferences and will be discussed with FDA and other authorities to support a possible regulatory submission in this indication, the press release stated.
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