Weekly Digest - 10-17 Mar 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - 10-17 Mar 2023
13 Mar 2023: Xtandi (Enzalutamide, Oral)/ mHSPC / Astellas / Pfizer: Phase 3 China ARCHES study meets primary endpoints Announced a clinical hold on its STING agonist ADC in Phase 1 trial
- Astellas announced positive topline results from the Phase 3 ARCHES study of Xtandi (Enzalutamide) plus ADT in men with mHSPC (metastatic hormone-sensitive prostate cancer)
- Statistically significant improvement in time to PSA (Prostate-specific antigen) progression (TTPP) : ≥25% increase & ≥2µ above the nadir
- Safety of Xtandi plus ADT was consistent with the known safety profile for Xtandi.
- Met secondary endpoints: Reduced risk of radiographic progression-free survival (rPFS) and increased the rate of patients with undetectable PSA vs placebo plus ADT.
- “… 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.” said Ahsan Arozullah, M.D., M.P.H., Sr. VP and HOD of Therapeutic Areas, Astellas
- Xtandi has not been approved by the NMPA for the treatment of mHSPC
