Pfizer and Astellas modify research protocols for ARCHES and EMBARK

23rd August 2018 (Last Updated August 23rd, 2018 00:00)

Pfizer and Astellas Pharma have amended the protocols of two registrational Phase lll trials, ARCHES and EMBARK, which aim to examine the safety and efficacy of XTANDI (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC).

Pfizer and Astellas Pharma have amended the protocols of two registrational Phase lll trials, ARCHES and EMBARK, which aim to examine the safety and efficacy of XTANDI (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC).

The modifications were made to expedite the timelines for the scheduled primary completion dates of both trials.

The amendments have revised the planned analyses of the primary and secondary endpoints of the ARCHES trial. In addition, the trial’s scheduled primary completion date has been moved forward from April 2020 to the end of this year.

In addition, the EMBARK trial’s planned analyses of the primary and several secondary endpoints were modified to reduce the target sample size.

The amendments have also changed the trial’s scheduled completion date from March 2021 to mid-2020.

"We continually strive to design and implement clinical trials that bring innovations to people with the greatest need."

Astellas Pharma Oncology Development senior vice-president and global therapeutic area head Steven Benner said: “We continually strive to design and implement clinical trials that bring innovations to people with the greatest need.

“With the amendments to ARCHES and EMBARK, we will be able to evaluate the potential of XTANDI for men with hormone-sensitive prostate cancer sooner, including for those with non-metastatic disease in which there are no currently approved oral treatment options.”

The ARCHES trial is a randomised Phase lll trial that aims to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in metastatic HSPC patients.

The trial’s primary endpoint is radiographic progression-free survival (rPFS). Patient enrolment for the trial was concluded earlier this year.

EMBARK is a randomised Phase lll trial of enzalutamide plus leuprolide, enzalutamide monotherapy, and leuprolide alone in men with high-risk non-metastatic HSPC.

Its primary endpoint is metastasis-free survival (MFS). The trial completed enrolling patients earlier this year.