Updates on Pfizer’s Xtandi
In a press release on August 22, Pfizer (PFE) and Astellas announced amendments for the clinical research protocols for ARCHES and EMBARK—two phase 3 studies evaluating Xtandi (enzalutamide) for treating patients with HSPC (hormone-sensitive prostate cancer).
The above chart shows the amendments for Pfizer’s Xtandi.
Xtandi is a prescription drug that treats prostate cancer. Xtandi patients aren’t responding to the medical or surgical therapies that lower testosterone. The drug is part of Astellas Oncology’s alliance with Pfizer. Pfizer commercializes the drug in the US markets.
About the amendments
On August 22, the companies announced the protocol amendments for the ARCHES and EMBARK studies—two phase 3 studies evaluating Xtandi. The changes accelerate the timelines for the anticipated primary completion dates for both of the trials.
ARCHES is a phase 3 trial evaluating Xtandi in combination with Androgen Deprivation Therapy in patients with metastatic HSPC. The radiographic progression-free survival is the primary endpoint for the trial. The companies enrolled patients in early 2018 and expect the primary completion date in late 2018—compared to the previous expected primary completion date in April 2020.
EMBARK is a phase 3 trial evaluating Xtandi (enzalutamide) in combination with leuprolide, enzalutamide as a monotherapy, and leuprolide only in patients with high-risk non-metastatic HSPC. Metastasis-free survival is the primary endpoint for the trial. The companies enrolled patients in early 2018. The expected primary completion date is mid-2020—compared to the previous expected primary completion date in March 2021.