- XTANDI® plus leuprolide significantly improves overall survival in non-metastatic hormone-sensitive prostate cancer.
- The Phase 3 EMBARK study shows a meaningful survival benefit with XTANDI plus leuprolide compared to placebo.
- XTANDI is the only androgen receptor inhibitor regimen demonstrating survival benefit in nmHSPC with high-risk BCR.
Pfizer Inc. (PFE, Financial) and Astellas Pharma Inc. have announced positive topline results from the EMBARK Phase 3 study, demonstrating that XTANDI® (enzalutamide) in combination with leuprolide significantly improves overall survival (OS) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence (BCR). This combination therapy showed a statistically significant and clinically meaningful improvement in OS compared to placebo plus leuprolide.
While XTANDI monotherapy presented a favorable trend towards improved OS compared to placebo plus leuprolide, the difference was not statistically significant. Importantly, no new safety signals were identified, aligning with the established safety profile of XTANDI.
The EMBARK trial, which involved 1,068 patients globally, demonstrated that XTANDI is the only androgen receptor inhibitor-based regimen to show a survival benefit in various stages of prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC), castration-resistant prostate cancer (mCRPC), and nmHSPC with high-risk BCR.
This significant finding is expected to broaden clinical confidence and offer improved therapeutic choices for men with high-risk BCR, potentially allowing them to live longer when initiating treatment with XTANDI earlier in their diagnosis.
"These results support the clinical practice of initiating XTANDI for men with nmHSPC and high-risk BCR," added Neal Shore, M.D., F.A.C.S., signaling a notable advancement in prostate cancer management.
