ESSA Pharma Inc. has announced the termination of its Phase 2 trial for masofaniten in combination with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC). The decision was based on interim data showing a lower PSA90 response rate compared to enzalutamide alone, and a lack of clear efficacy benefit with the combination. ESSA is also halting other masofaniten studies and will focus on its remaining resources.
Astellas Pharma Inc. announced the European Commission (EC) has approved a label extension for XTANDI® (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
The EC approval is based on results from the Phase 3 EMBARK trial, which showed XTANDI in combination with leuprolide led to a 57.6% lower risk of disease progression or death compared to leuprolide alone. Treatment with XTANDI alone was associated with a 36.9% reduction in risk. The European Association of Urology (EAU) guidelines recommend XTANDI for men with high-risk BCR nmHSPC with or without ADT, after radiation therapy or surgery.
XTANDI is an androgen receptor signaling inhibitor indicated in the EU for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC), and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR).
