David Delgado
Pfizer (New York Stock Exchange: PFE) and Astellas Pharma Inc. (OTCPK:ALPMF) (OTCPK:ALPMY) found that Xtandi (enzalutamide) and leuprolide significantly reduced the risk of metastasis or death in patients with certain stages of prostate cancer by 58% compared to leuprolide in combination with placebo. said to have been reduced. 3 trials.
of the company had report Data from the late-stage trial, named EMBARK, was announced in March, with full data presented at the American Urological Association Annual Meeting on April 29.
The trial evaluated patients in three study groups (Xtandi plus leuprolide). [n=355]placebo and leuprolide [n=358]or Xtandi monotherapy [n=355]) Men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also called non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).
The primary goal of this study was metastasis-free survival (MFS).
The companies said statistically significant and clinically meaningful improvements were also seen in key secondary objectives in the Xtandi combination and monotherapy arms, consistent with the study’s primary objective.
The Xtandi monotherapy group met its MFS goal with a 37% reduction in the risk of metastasis or death compared to leuprolide plus placebo.
Treatment with Xtandi plus leuprolide and Xtandi monotherapy reduced the risk of PSA progression by 93% and 67%, respectively, compared to placebo and leuprolide.
The risk of progression when starting a new anti-tumor therapy was reduced by 64% with Xtandi plus leuprolide and 46% with Xtandi alone compared to the leuprolide placebo combination.
The companies added that a positive trend in overall survival (OS), the primary secondary target, was seen in the Xtandi combination arm, but the data are not yet mature.
This data has been discussed with regulatory authorities, including in the United States, and supports the potential submission of Xtandi for this indication to regulatory authorities in 2023.
The results indicate that Xtandi, if approved, could be added to the standard of care for prostate cancer.
