XTANDI Extends Survival in Metastatic Hormone-Sensitive Prostate Cancer

Key Highlights:

• Five-year follow-up from the Phase 3 ARCHES study shows XTANDI plus ADT reduces risk of death by 30% in men with mHSPC.
• Two-thirds of patients with mHSPC now survive five years with XTANDI treatment, marking a significant shift in long-term outcomes.
• XTANDI becomes the first AR inhibitor to demonstrate sustained five-year overall survival in metastatic hormone-sensitive prostate cancer.

Astellas Pharma and Pfizer have reported new updated long-term results from the open-label extension portion of the Phase 3 ARCHES study that utilized a five-year follow-up to demonstrate continued overall survival (OS) benefits.

Results demonstrated that men with metastatic hormone-sensitive prostate cancer (mHSPC) who received XTANDI (enzalutamide), an androgen receptor pathway inhibitor (ARPI), with androgen deprivation therapy (ADT) observed a 30 percent decrease in risk of death compared to patients receiving placebo plus ADT.

Also read: Building a Successful Pharma Brand in India: The Role of Scientific Communication

Andrew J. Armstrong, MD, ScM, Director of Research at the Center for Prostate & Urologic Cancers, Duke Cancer Institute, Durham, NC, and ARCHES primary investigator said, “Historically, the likelihood of survival at five years for men with metastatic hormone-sensitive prostate cancer was low, but with advancements in initial treatment intensification like what we’ve seen with XTANDI, this is now becoming the standard.”

“In our five-year follow up of the global ARCHES trial, two-thirds of men are now surviving five years, representing a 13 percent  absolute and 30 percent relative improvement over standard hormonal therapy alone, with benefits in patients with high and low disease burden that are meaningful to our patients,” he added.

“Until recently, patients with metastatic hormone-sensitive prostate cancer faced a poor prognosis, particularly in advanced stages, often due to treatment resistance. As the only androgen receptor inhibitor demonstrating sustained five-year survival in this patient population, these data further reinforce XTANDI combined with androgen deprivation therapy as the standard-of-care for treating this advanced disease,” said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer.