Enzalutamide Combined with Leuprolide Reduces Risk of Metastasis or Death by 58% in nmHSPC, According to Phase 3 EMBARK Trial

On April 29, Astellas and Pfizer jointly announced that in the Phase III EMBARK study, compared with placebo + leuprolide, enzalutamide (brand name: Xtandi) + leuprolide reduced the risk of metastasis or death by 58% in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC, also known as non-metastatic castration-sensitive prostate cancer, or nmCSPC).

On March 16, Astellas and Pfizer announced that the EMBARK study met its primary endpoint, with enzalutamide plus leuprolide statistically improving metastasis-free survival (MFS) in patients.

EMBARK is a randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of enzalutamide monotherapy or in combination with leuprolide in high-risk biochemical recurrence (BCR) patients with nmHSPC. The study enrolled 1068 participants, randomly divided into three groups receiving enzalutamide + leuprolide (n=355), enzalutamide monotherapy (n=355), and placebo + leuprolide (n=358).

Consistent with the primary endpoint, the secondary endpoints of the enzalutamide plus leuprolide group and the enzalutamide monotherapy group also showed statistically significant and clinically meaningful improvements. Compared with placebo plus leuprolide, enzalutamide monotherapy reduced the risk of metastasis or death by 37%; enzalutamide plus leuprolide and enzalutamide monotherapy reduced the risk of prostate-specific antigen (PSA) progression by 93% and 67%, respectively, and reduced the risk of starting new anti-tumor treatment by 64% and 46%, respectively.

Moreover, the overall survival (OS) in the enzalutamide plus leuprolide group showed a positive trend, but the data are not yet mature. Patients in the trial will continue to be followed up for the final OS analysis. The overall safety profile is consistent with the known safety of each drug.

Enzalutamide, whether in combination with leuprolide or as monotherapy, has not been approved by any regulatory agency for the treatment of nmHSPC patients with high-risk BCR.

Reference Source:

https://www.pfizer.com/news/press-release/press-release-detail/xtandir-enzalutamide-plus-leuprolide-reduced-risk

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