XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT

Study enrolled 180 men with metastatic hormone-sensitive prostate cancer in mainland China

TOKYO, MARCH 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) versus placebo plus ADT. The study met its primary endpoint, demonstrating a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP), defined as a ≥ 25% increase and an absolute increase of ≥ 2 µg/L (2 ng/mL) above the nadir (i.e., lowest PSA value observed post baseline or at baseline), which is confirmed by a second consecutive value at least 3 weeks later. At the topline analysis, the safety of XTANDI plus ADT was broadly consistent with the known safety profile for the medication.

The study also met key secondary endpoints, demonstrating that treatment with XTANDI plus ADT notably reduced the risk of radiographic progression-free survival (rPFS) and increased the rate of patients with undetectable PSA versus placebo plus ADT.

“With the rising incidence of prostate cancer diagnoses among men in China, there is a need for new and effective treatment options,” said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. “As observed in our global Phase 3 ARCHES study, and now reaffirmed with China ARCHES, XTANDI significantly delays the time to disease progression in men with mHSPC and may provide an important treatment option for men in China if approved.”

“While past global studies have supported the use of XTANDI plus ADT in men with mHSPC, it is encouraging to see these results replicated for patients in mainland China,” said Prof. Zhou Fangjian, Head of Urology Department, Sun Yat-sen University Cancer Center, Sun Yat-sen University.

“As an existing standard of care for Chinese men with castration-resistant prostate cancer, XTANDI has the potential to help men earlier in their treatment journey – before their disease stops responding to therapies that lower testosterone,” said Prof. Ye, Dingwei, Vice President of the Fudan University Shanghai Cancer Center, Director of the Multi-disciplinary Team for GU Cancer.

Detailed results from China ARCHES will be submitted for publication in the near future. Data from China ARCHES will be shared with the China National Medical Products Administration (NMPA) to potentially support a regulatory filing.

XTANDI has not been approved by the NMPA for the treatment of mHSPC.

This result will have no impact on the financial forecasts of the current fiscal year ending March 31, 2023.


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