Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that its prostate cancer therapy, Xtandi (enzalutamide), is poised to add a new indication for the China market following positive results from the Phase III China ARCHES study. The trial evaluated Xtandi in combination with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo plus ADT.
Study Findings
The study met its primary endpoint by achieving at least a 25% improvement in time to prostate-specific antigen (PSA) progression (TTPP). It also confirmed the safety of Xtandi plus ADT in the targeted population and reached secondary endpoints by reducing the risk of radiographic progression-free survival (rPFS) and increasing the rate of patients with undetectable PSA. These results align with those from the global ARCHES trial.
Market Context and Previous Approvals
Xtandi is an oral androgen receptor (AR) antagonist administered once per day. It was first approved in China in November 2019 for treating castration-resistant prostate cancer in patients previously treated with ADT and prior to chemotherapy. A second indication for non-metastatic castration-resistant prostate cancer (nmCRPC) was awarded in November 2020. Generic versions from Qilu Pharmaceutical Co., Ltd, and Jiangsu Hansoh Pharmaceutical Co., Ltd, were approved for market in 2021 and 2023, respectively, while Xtandi has been reimbursed nationally in China since 2020.
Significance of the Expansion
The potential expansion of Xtandi’s indications in China underscores Astellas Pharma’s commitment to providing effective treatment options for prostate cancer patients. This development is expected to enhance the drug’s accessibility and impact on patient outcomes in the region.-Fineline Info & Tech
