AOJ-1 - Asia as a center for global oncology drug development

Abstract

We are all familiar with the fact that certain cancers, such as gastric and esophageal cancers and hepatocellular carcinoma, are more prevalent in Asia than in the West. A common misperception is that Asian expertise and access to patients is limited to these Asia-prevalent cancers. On the contrary, Japanese, Korean, and Chinese researchers have played key roles in recent advances in the treatment of geographically non-specific tumors such as non-small cell lung cancer (NSCLC). In fact, Asian investigators and Asia-led studies have been pivotal in the development of important targeted agents in diseases including EGFR mutant and ALK rearranged NSCLC. When deciding whether to pursue a worldwide integrated development plan or separate Western and Asia development plans, several key considerations should be taken into account: Is there similar etiology and histology of the disease? Are patients staged similarly with other parts of the world? Is there similar clinical utilization of surgery, radiation, chemotherapy, loco-regional therapy, targeted therapy, and immunotherapy? Are there similar outcomes in terms of response and survival? Are salvage treatments similarly available and effective in Asia as in other parts of the world? Is there any reason to believe that the tolerability or risk/benefit ratio of the drug or intervention will be different in Asian patients? Does the infrastructure exist for efficient monitoring of Asian sites? Can biological specimens be obtained from patients and, if so, can the tissue be analyzed in a laboratory outside of the region? Inclusion of Asian patients in pivotal clinical trials is a requirement for market access in many Asian countries. Global pharmaceutical companies must decide whether to include Asian sites in global pivotal trials or to pursue Asia-focused clinical development strategies. Successful companies will utilize both approaches, tailoring them to the unique characteristics of the population, disease, and product.