Astellas Pharma and Pfizer reported that the phase 3 ARCHES trial evaluating XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint, improving radiographic progression-free survival (rPFS) significantly in comparison to ADT alone.
The preliminary safety analysis of the ARCHES trial appears consistent with the safety profile of XTANDI in previous clinical trials in castration-resistant prostate cancer (CRPC). Detailed results will be submitted for presentation at an upcoming medical congress.
Pfizer global product development oncology chief development officer Mace Rothenberg said: “While XTANDI is currently approved for both metastatic and non-metastatic CRPC, there still remains a need for more treatment options for men with metastatic hormone-sensitive prostate cancer.
“With these top-line results, we believe XTANDI has the potential to help men whose disease has progressed outside the prostate gland, but still responds to treatment to lower testosterone.”
Astellas senior vice president and oncology development global therapeutic area head Steven Benner said: “The results from ARCHES demonstrate a statistically significant improvement in a key marker of disease progression – radiographic progression-free survival.
“Based on the top-line results of ARCHES, we look forward to discussing the data with relevant health authorities to potentially support expanding the indication for XTANDI.”
XTANDI is currently approved in the U.S. and Japan for the treatment of CRPC and in the EU for the treatment of metastatic and high-risk non-metastatic CRPC. Since its initial approval in 2012, XTANDI has been prescribed to more than 330,000 men worldwide.
Source: Company Press Release