Astellas Clears Primary Endpoints In Prostate Cancer And Menopause Trials

Astellas has announced that its therapy for prostate cancer has reached its primary endpoint in a Phase 3 trial in China. The Arches study of Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) showed a statistically significant improvement in time to disease progression compared to placebo. 

In another announcement, the company welcomed the publication of a Phase 3 trial of fezolinetant in vasomotor symptoms (VMS) due to menopause in The Lancet. 

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Xtandi Delays Prostate Cancer Progression  

In Arches (China), Xtandi plus ADT delayed the progression of prostate cancer, defined in the trial as a 25% increase and an absolute increase of ≥ 2 µg/L (2 ng/mL) above prostate-specific antigen (PSA) levels observed at baseline. 

The findings were confirmed by a second consecutive value three weeks later. The safety of the regimen also checked out with the known safety profile from previous clinical trials. 

Furthermore, the treatment reduced the risk of radiographic progression-free survival (rPFS) and increased the rate of patients with undetectable PSA versus placebo plus ADT, meeting key secondary endpoints. 

“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 Archws, 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.”

Detailed results from Arches (China) will be submitted for publication in the near future, said Astellas, adding that the data will be shared with the China National Medical Products Administration to support a filing for approval. 

Fezolinetant Meets Primary Endpoints for Vasomotor Symptoms in Menopause

In a separate development, Astellas has announced the publication of results from the pivotal Phase 3 Skylight study of fezolinetant in The Lancet. 

Fezolinetant is an oral nonhormonal compound designed to treat moderate to severe vasomotor symptoms (VMS) due to menopause. VMS is characterized by hot flashes and/or night sweats, both common symptoms of menopause. 

The Skylight study met four coprimary efficacy endpoints. The 30 and 45 mg doses of fezolinetant, given once daily, showed statistically significant improvements from baseline in VMS frequency and severity at 4 and 12 weeks compared to placebo. 

The benefits of the drug were observed as early as week 1, and were sustained throughout the rest of the 52-week trial period. 

While improvements in sleep disturbance were observed with fezolinetant treatment, neither dose met statistical significance at 12 weeks according to the sleep disturbance scoring system. However, the drug demonstrated a significant and clinically meaningful improvement at 4 and 12 weeks on a Menopause-Specific Quality of Life (MENQOL) questionnaire, which was maintained through 52 weeks. 

The safety profile of fezolinetant, observed during the 40-week extension period, was consistent with that of the 12-week placebo-controlled period. Side effects associated with treatment occurred in 37% of patients treated with 30 mg fezolinetant and 43% with the 45 mg dose, compared to 45% of placebo participants. 

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Joy Lin

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