On November 20, 2017 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported 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 (Press release, Daiichi Sankyo, NOV 20, 2017, View Source [SID1234522175]).
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"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.1 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.2 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."
About DESTINY-Gastric01
DESTINY-Gastric01 is a pivotal phase 2, open-label study investigating the safety and efficacy of DS-8201 in patients with HER2-expressing advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3+ or IHC2+/ISH+) who have progressed on two prior regimens including fluoropyrimidine agent, platinum agent and trastuzumab. Patients will be randomized 2:1 to DS-8201 or physician’s choice of treatment (paclitaxel or irinotecan monotherapy). The primary endpoint of the study is objective response rate. Secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, time to treatment failure, pharmacokinetics and safety.
DESTINY-Gastric01 also will include two non-randomized exploratory cohorts to examine the safety and efficacy of DS-8201 in patients with HER2 low-expressing advanced gastric cancer, who have not been treated previously with a HER2-targeting therapy. The first exploratory cohort will enroll patients with HER2 low-expression defined as IHC2+/ISH-, and the second exploratory cohort will include HER2 low-expression defined as IHC1+.
The study is expected to enroll up to 180 patients in the pivotal cohort and 40 patients in the exploratory cohorts in Japan and South Korea. For more information about this clinical trial, visit www.ClinicalTrials.gov.