Pfizer and Astellas Report Positive Phase 3 Results for Prostate Cancer Drug XTANDI

Pfizer and Astellas' Positive Results Mark a Significant Improvement

Image Credits: The Astellas US Newsroom

Announcement

Pfizer Inc. and Astellas Pharma Inc. proved their potential with the positive results directly from the overall survival (OS) analysis from its phase 3 study of EMBARK. A study evaluates XTANDI® (enzalutamide), merging with leuprolide and asa monotherapy for men with non-metastatic hormone-sensitive prostate cancer that is also called nonmetastatic castration-sensitive prostate cancer or nmCSPC, including biochemical recurrence (BCR) at a risk for metastasis.

Role of EMBARK

The patients with XTANDI plus leuprolide versus placebo plus leuprolide can approach EMBARK. EMBARK has successfully met the secondary endpoint with its clinically proven improvement and efforts in OS. The results highlight an effective trend for an improvement in OS for patients with XTANDI monotherapy versus placebo plus leuprolide. Though the difference in the results doesn’t meet the statistical significance. There was no additional or newly discovered safety in the analysis, so the safety results were similar to the standard safety profile of XTANDI.

The EMBARK study covered random patients to one study. XTANDI plus leuprolide, placebo plus leuprolide or XTANDI monotherapy the three study arms were the most focused areas. The initial analysis was earlier mentioned in the New England Journal of Medicine in 2023, which described the study. The study learned that it met its primary endpoint with clinical improvement in MFS, and showed statistically significant results for patients with XTANDI plus leuprolide versus placebo plus leuprolide. The normal negative events to this compiled group of studies were fatigue and hot flashes. The negative events in the monotherapy group are fatigue, gynecomastia, and hot flashes. XTANDI has received approval in more than 80 countries, including Japan, the European Union, and the United States.

Views and Statements

F.A.C.S., START Carolinas/Carolina Urologic Research Center, MD, Neal Shore said, “The data elaborates the treatment with XTANDI as a life-expanding solution for men with nmHSPC and also treats patients with high-risk BCR that have relapsed after the curative-intent therapy with prostatectomy, radiation therapy. Further, the validation of EMBARK’s metastasis-free survival data is additional. The results show benefits for OS and MFS.”

Oncology Chief Development Officer of Pfizer, MD, Johanna Bendell, said, “XTANDI is the only androgen receptor inhibitor-based regimen to show survival benefit in nmHSPC and metastatic HSPC with high-risk BCR, also in castration-resistant prostate cancer that shows potential and patient impact in advanced prostate cancer.” Further, “the positive results are an addition to the clinical support."