Daiichi Sankyo Company, Limited has announced the first patient has been enrolled in DESTINY-Gastric01, a pivotal phase 2 study in Japan and South Korea evaluating the safety and efficacy of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma resistant or refractory to trastuzumab.
“Japan and South Korea have some of the highest rates of gastric cancer worldwide and there have been limited advances in targeted treatments over the past decade,” said Koichi Akahane, PhD, MBA, executive officer, head of oncology function, R&D division, Daiichi Sankyo. “The initiation of this pivotal study will allow us to evaluate whether the smart delivery of chemotherapy with DS-8201 may be a potential new treatment option to help address the high unmet medical need of gastric cancer.”
Approximately one in five gastric cancers overexpress HER2, a tyrosine kinase receptor growth-promoting protein found on the surface of some cancer cells. HER2-expressing gastric cancer is an area of unmet medical need as advances in the treatment of the disease have been limited, largely due to its genetic complexity and heterogeneity. Currently, no approved HER2-targeting therapy options exist for patients with HER2-positive advanced gastric cancer after trastuzumab.
“We are excited to initiate this second pivotal study of DS-8201 as it represents an important next step to accelerate the development of DS-8201,” said Antoine Yver, MD, MSc, executive vice president and global head, oncology research and development, Daiichi Sankyo. “With limited treatment options available for advanced gastric cancer, including no approved antibody drug conjugate, we are exploring the potential of DS-8201 as a new treatment option for this type of HER2-expressing cancer.”