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 -microg/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
'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
'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
Detailed results from China ARCHES will be submitted for publication in the near future. Data from China ARCHES will be shared with the
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
About Metastatic Hormone-Sensitive Prostate Cancer
In
About the China ARCHES Trial
The company-sponsored, multicenter, Phase 3, randomized, double-blind, placebo-controlled China ARCHES trial (NCT04076059) enrolled 180 Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC) across 30 sites in mainland
About XTANDI (enzalutamide soft capsules)
Enzalutamide is an androgen receptor signaling inhibitor indicated for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high-risk of metastasis or metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated.6
About Astellas
About the
In
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.
Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Conatct:
Tel: (847) 942-0980
Email: cassie.hogenkamp@astellas.com
(C) 2023 Electronic News Publishing, source