One of the world’s largest pharmaceutical companies, Pfizer Inc. and the Japanese drug manufacturer Astellas Pharma Inc. have recently announced that they will be amending the protocols for two late-stage trials designed to test the XTANDI prostate cancer drug with an aim to speed up completion.
Reuters reports that the companies are now planning the end of the ARCHES trial late in 2018 instead of its previously anticipated end date in April 2020. The EMBARK trial is expected to be completed by middle of 2020 instead of the previously set goal of March 2021. Both trials were designed to test the efficacy and safety of XTANDI which is being developed to treat men with hormone-sensitive prostate cancer.
ARCHES is a registrational Phase 3 trial that is meant to evaluate the efficacy of enzalutamide plus androgen deprivation therapy versus androgen deprivation therapy alone in metastatic hormone-sensitive prostate cancer patients. Changes to the protocol will revise the primary endpoint of the trial which is basically radiographic progression-free survival. Revision will also occur in secondary endpoints.
EMBARK is a randomized Phase 3 evaluation of enzalutamide monotherapy, leuprolide alone and enzalutamide plus leuprolide in men with high-risk non-metastatic hormone-sensitive prostate cancer. The amendment of the protocols will mean the revision of the primary endpoint which is metastasis-free survival and the revision of several secondary endpoints which will effectively reduce the target sample size.
Steven Benner, senior VP and global therapeutic area head at Astellas, Oncology Development has been reported to say that the company worked hard to design clinical trials that facilitate innovations to reach people in need. With the amendments in EMBARK and ARCHES, patients with hormone-sensitive prostate cancer would be able to avail XTANDI sooner. Patients with non-metastatic disease will also benefit from the move as there are no approved oral treatment options available for the disease at present.
Incidentally, the U.S. Food and Drug Administration has already approved XTANDI for the treatment of castration-resistant prostate cancer.