125IN - How Can Pharmaceutical Companies Facilitate Global Collaboration in Phase 1 Cancer Drug Development in Asia?

Abstract

ABSTRACT Modern oncology drug development is a worldwide enterprise, and large Phase 3 registration trials are commonly conducted around the globe. However, in many pharmaceutical companies, early oncology clinical trials designed to establish proof of concept have been slower to adopt a global footprint. Historically, many western companies focused their early development efforts in specialized Phase 1 centers concentrated in western countries. Only after POC was established were programs expanded into other parts of the world such as the Asia-Pacific region. In countries such as Japan, this contributed to a delay in approval times compared with western countries; a disparity referred to as the drug lag (Ueno et al Clin Pharm Therap 2014). With the ever accelerating pace of oncology therapeutics, this lag is no longer acceptable, and efforts are underway to close this gap. Many companies are looking to initiate Asia-Pacific pre-POC clinical trials at an earlier stage, especially when there is strong therapeutic promise in areas of high unmet medical need in the region, such as liver, gastric, lung, and esophageal cancers. However, this presents many new challenges, including the requirement for close communication and coordination of early development programs globally when the drug's safety and efficacy profiles are still not defined. Furthermore, all new targeted therapy programs have companion diagnostic strategies integral to their success, and in early development many of these predictive biomarkers are still exploratory. Success also requires regional expertise in early trials and translational research on the part of the company's R&D staff and their collaborating investigators. Asian patient populations and their concomitant diseases may differ from their western counterparts. For example, the frequency of EGFR mutations in Asian patients with adenocarcinoma of the lung is vastly different than in the west. Finally, additional challenges can arise in Asia during regulatory review of early studies, and when clinical specimens must be shipped to specialized centers for predictive biomarker analysis. Nonetheless, the marked advantage of accelerating global early development oncology programs makes it essential that these obstacles be overcome. Disclosure: C.H. Takimoto: I am an employee and stock holder of Johnson & Johnson.