Pfizer and Astellas amend clinical research protocols for two phase 3 trials of enzalutamide in patients with hormone-sensitive prostate cancer

PfizerPfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI® (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC). These amendments accelerate timelines for the anticipated primary completion dates of both trials.

ARCHES is a randomized Phase 3 study evaluating the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus ADT alone in metastatic HSPC patients. The primary endpoint of the trial is radiographic progression-free survival (rPFS). Changes to the protocol include revision of the planned analyses of the primary and secondary endpoints. Enrollment was completed earlier this year. The companies now anticipate the primary completion date for the ARCHES clinical trial to be in late 2018. The previously expected primary completion date was April 2020.

Revisions were also made to the protocol for EMBARK, a randomized Phase 3 study of enzalutamide plus leuprolide, enzalutamide monotherapy, and leuprolide alone in men with high-risk non-metastatic HSPC. The primary endpoint of the trial is metastasis-free survival (MFS). The main purpose of the amendment is to revise the planned analyses of the primary and several secondary endpoints, which reduced the target sample size. Enrollment was completed earlier this year. With these changes, the estimated primary completion date for the EMBARK clinical trial is mid-2020. Previously, the expected primary completion date for EMBARK was March 2021.

"We continually strive to design and implement clinical trials that bring innovations to people with the greatest need," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "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."

"With a large body of evidence demonstrating the activity of XTANDI in men with castrate-resistant prostate cancer, ARCHES and EMBARK are designed to extend the evaluation of XTANDI to men with hormone-sensitive prostate cancer," said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. "Our goal is to build upon the body of clinical evidence for enzalutamide in an effort to help address the unmet needs of an even broader spectrum of prostate cancer patients."

XTANDI is approved by the U.S. Food and Drug Administration for the treatment of castration-resistant prostate cancer.

Details regarding ARCHES (NCT02677896) and EMBARK (NCT02319837) are available on ClinicalTrials.gov.

About Pfizer Oncology

Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on people living with cancer. Our growing pipeline of biologics, small molecules, and immunotherapies is focused on identifying and translating the best scientific breakthroughs into clinical application for patients across a diverse array of solid tumors and hematologic cancers. Today, we have 10 approved oncology medicines and 14 assets currently in clinical development. By maximizing our internal scientific resources and collaborating with other companies, government and academic institutions, as well as patients and non-profit and professional organizations, we are bringing together the brightest and most enterprising minds to take on the toughest cancers. Together we can accelerate breakthrough treatments to patients around the world and work to redefine life with cancer.

About Astellas

Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

About the Pfizer/Astellas Collaboration

In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.

Most Popular Now

Cancer cells are quick-change artists adapting to …

Until now, researchers have assumed that the growth of solid tumors originates from cancer stem cells characterized by specific surface markers, which develop in a fixed...

Nucala (mepolizumab) gains FDA approval for two ne…

GlaxoSmithKline (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjec...

Cannabis use among older adults rising rapidly

Cannabis use among older adults is growing faster than any other age group but many report barriers to getting medical marijuana, a lack of communication with their docto...

Jeff Settleman, Ph.D., joins Pfizer to lead Oncolo…

Pfizer Inc. (NYSE: PFE) announced that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading al...

Cleveland researchers test novel gene therapy for …

A novel gene therapy clinical trial at University Hospitals Seidman Cancer Center and the Case Comprehensive Cancer Center is showing promising results, garnering funding...

Full data from CAROLINA® outcome trial support lon…

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced full data from the CAROLINA® trial demonstrating that Trajenta® (linagliptin) did not increase cardio...

Merck pioneers new effort to see MS from the insid…

Merck, a leading science and technology company, joins the global multiple sclerosis (MS) community in recognition of World MS Day, an initiative created by the Multiple ...

Bristol-Myers Squibb announces post-closing leader…

Bristol-Myers Squibb Company (NYSE:BMY) today announced the future leadership team of the combined company effective upon completion of the company’s pending merger with ...

Novartis Kisqali significantly extends life in wom…

Novartis announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy[1]. The Phase 3 MONALEESA-7 trial evaluated K...

Amgen joins with community oncology networks for n…

Amgen (NASDAQ: AMGN), along with leading community oncology networks, today announced the launch of Amgen Community Oncology Research Collaborators (ACORC), a new initiat...

Bayer receives U.S. FDA breakthrough therapy desig…

Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for copanlisib (Aliqopa™) for the treatment of adult patie...

Prescription drug costs steadily soar, yet price t…

After reviewing tens of millions of insurance claims for the country’s 49 most popular brand-name prescription drugs, a team from Scripps Research Translational Institute...