Xtandi (Enzalutamide) Becomes First Global Therapy Approved for Early-Stage High-Risk Non-Metastatic Hormone-Sensitive Prostate Cancer

On November 17, Astellas and Pfizer jointly announced that a new indication for enzalutamide (brand name: Xtandi) has been approved by the FDA for marketing. It is used in combination with or without gonadotropin-releasing hormone (GnRH) analogs to treat non-metastatic hormone-sensitive prostate cancer (nmHSPC, also known as non-metastatic castration-sensitive prostate cancer, nmCSPC). The press release noted that this is the world's first approved androgen receptor inhibitor for treating high-risk non-metastatic castration-sensitive prostate cancer.

This approval is mainly based on the positive results of the Phase III EMBARK study. This study aims to evaluate the efficacy and safety of enzalutamide monotherapy or in combination with leuprolide in treating high-risk biochemical recurrence (BCR) patients with nmHSPC. The study included 1,068 participants, randomly divided into three groups: receiving enzalutamide + leuprolide (n=355), enzalutamide monotherapy (n=355), and placebo + leuprolide (n=358).

The study results showed that the primary endpoint was reached, and Enzalutamide + Leuprolide statistically improved metastasis-free survival (MFS) in patients. Compared with placebo + Leuprolide, Enzalutamide + Leuprolide reduced the risk of metastasis or death by 58% in patients with non-metastatic hormone-sensitive prostate cancer.

Enzalutamide + Leuprolide and Enzalutamide Monotherapy Show Statistically Significant and Clinically Meaningful Improvements in Secondary Endpoints. Compared with placebo + leuprolide, enzalutamide monotherapy reduced the risk of metastasis or death by 37%; enzalutamide + leuprolide and enzalutamide monotherapy reduced the risk of prostate-specific antigen (PSA) progression by 93% and 67%, respectively, and reduced the risk of initiating new anticancer therapy by 64% and 46%, respectively.

In addition, the overall survival (OS) of the enzalutamide + leuprolide group showed a positive trend, but the data is 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 profiles of each drug.

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