Astellas Submits New Drug Application for Enzalutamide to Treat Metastatic Hormone-Sensitive Prostate Cancer in China

On September 19, Astellas announced that the new indication application for enzalutamide (brand name: Xtandi, Ancotan) has been accepted by the CDE for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

This new indication application is based on the results of the Chinese ARCHES Phase III study. This is a multi-center, randomized, double-blind, placebo-controlled Chinese Phase III trial (NCT04076059), which enrolled 180 Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC) across 30 research centers in mainland China. Patients were randomly assigned to receive either enzalutamide combined with androgen deprivation therapy or placebo combined with androgen deprivation therapy.

The results showed that the study met its primary endpoint, demonstrating a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP). PSA progression was defined as an increase in PSA levels of ≥25% from the lowest PSA value (i.e., the lowest PSA level observed at or after baseline) with an absolute value of ≥2 µg/L (2 ng/mL), confirmed by a second consecutive measurement at least 3 weeks later.

The ARCHES study also met the key secondary endpoint, indicating that Enzalutamide combined with ADT significantly reduced the risk of radiographic progression-free survival (rPFS), and increased the rate of patients reaching undetectable PSA levels compared to placebo combined with ADT. In terms of safety, the safety profile of Enzalutamide combined with androgen deprivation therapy was generally consistent with the known safety profile of the drug.

Enzalutamide is an androgen receptor signaling inhibitor that has been approved in China for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis, as well as adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or have mild symptoms and have not received chemotherapy after the failure of androgen deprivation therapy (ADT).

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