NEWS RELEASE（Detail）

July 6, 2023
EPS Corporation

EPS Supported Important Japan-led
International Investigator-Initiated
HR+/HER2- Breast Cancer Study in Asia Pacific

EPS Corporation (EPS, a CRO company based in Tokyo, CEO: Akira Sasa) and George Clinical (based in Sydney, Australia) are supporting on an academia-led international study that is pioneering in Japan, seeking to provide additional treatment options for unmet needs in Asian populations.

From January 2017, EPS joined the National Cancer Center Hospital (NCCH) initiated study " Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ±Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer（PATHWAY/NCCH1607）”, aimed at investigating a potential new combination therapy. The PATHWAY trial is a clinical research collaboration between the National Cancer Center Hospital and Pfizer Inc., a research funder and a study drug provider.
EPS and George Clinical formed a strategic partnership in 2019 to help expand their operations across the Asia-Pacific region. Together the organizations have partnered on over 20 studies, mainly in oncology, kidney, metabolic and cardiovascular disease therapeutic areas. In this reciprocal strategic partnership, both companies come together to provide a seamless operating capability for clinical trials across the Asia-Pacific region and globally.
The two companies have been collaborating on the PATHWAY study in Singapore and Taiwan since 2019.

The NCCH run PATHWAY study is especially important, as Japanese investigator/academia-led international clinical trials have rarely been conducted due to language barriers, personnel shortage, or limited research budget.

In 2016, among all the Clinical Research Core Hospitals in Japan, NCCH was selected by AMED (Japan Agency for Medical Research and Development) as one of the Core Global Clinical Trails Centers, focused on the reinforcement of facilitating international clinical trials in Japan between 2016-2018. The PATHWAY study is their first international investigator-initiated registration-directed trial (IIRDT: Investigator Initiated Registration Directed Trial) - an important step toward the pursuit of the development of treatments and new drugs for the Asian population.

EPS worked closely with NCCH, the sponsor of the PATHWAY study, providing supports across multiple areas including project management, site management, monitoring, data management, statistics analyzation, CSR writing, site audit and the administrative works in the Independent Imaging review Committee Office to ensure the smooth progress of the study conducted in Japan, South Korea, Singapore and Taiwan. George Clinical was responsible for study execution in Singapore and Taiwan with specific duties including regulatory, safety reporting and site monitoring since 2019.

This study exemplifies the value of the strategic partnership of two highly experienced CROs who combine their services to ensure that a sponsor's study is conducted in the most efficient and effective manner to help bring new and advanced treatments to underserved patients. Both EPS and George Clinical have a proven track record of meeting a sponsor's needs with proactive solutions to challenges and on the ground knowledge of sites, local key opinion leaders and country-specific culture related knowledge. This is especially valuable regarding the specific regulatory requirements in different locations with local language and cultural expertise.

This Phase III trial has met its primary endpoint of demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of palbociclib plus tamoxifen compared with placebo plus tamoxifen in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer.
NCCH believes the results of this trial have a high impact for premenopausal breast cancer patients, for which a large percentage of patients exist in Asia Pacific with fewer treatment options. Detailed efficacy and safety results are presented at ASCO 2023.

Based on the experience and network gained from this trial, NCCH continues to expand the research network through the Asia Clinical Trials Network for Cancers Project (Asian clinical TriaLs network for cAncerS project；ATLAS project) with the mission to create a multinational cancer clinical trial network and a sound structure for conducting international collaborative trials on a permanent basis in the Asian region.

About PATHWAY Study

For details about PATHWAY please refer to National Cancer Center Hospital’s website
https://www.ncc.go.jp/jp/ncch/information/2023/0220/index.html

About EPS Corporation

EPS launched its business in 1991 as a CRO^*1 to comprehensively support clinical studies with the focus on clinical trials and PMS^*2. The company proposes new models to satisfy customers’ needs by leveraging its data science expertise and digital technology cultivated through its extensive track record. These proposals are founded in its Trial GATE concept, which acts as the gateway for all promotion functions of clinical trials.

Website:

https://www.epsi-global.com/index.html and

https://www.eps.co.jp/en/

LinkedIn:

https://www.linkedin.com/company/eps.corp/

About George Clinical

George Clinical is a leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence. With over 20 years of experience and more than 450 people managing over 39 geographical locations throughout the Asia-Pacific region, USA, and Europe, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trials.

Website:

https://www.georgeclinical.com

LinkedIn:

https://www.linkedin.com/company/george-clinical-pty-ltd

Twitter:

https://twitter.com/george_clinical

Facebook:

https://www.facebook.com/georgeclinical

WeChat:

https://mp.weixin.qq.com/

• *1　CRO：Contract Research Organization
• *2　PMS：Post Marketing Surveillance