The first patient has been treated in the DESTINY-Gastric04, a global phase 3 trial evaluating the safety and efficacy of ENHERTU (trastuzumab deruxtecan), compared to ramucirumab/paclitaxel combination therapy in patients with HER2 positive metastatic and/or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after a trastuzumab-containing regimen.
Gastric cancer is associated with a poor prognosis, particularly in the advanced stages of the disease, with only 5% to 10% of patients surviving five years. One in five gastric cancers are considered HER2 positive, however loss of HER2 expression has been observed in 29% to 69% of patients with gastric cancer following treatment with trastuzumab, suggesting a decrease in HER2 expression can result in progression on trastuzumab and may be associated with poor outcomes. After progression on first-line HER2 targeted systemic treatment, second-line treatment options are limited, driving a need for new HER2 targeted therapies for these patients.
“In the DESTINY-Gastric04 phase 3 trial, we are evaluating whether ENHERTU will improve survival as compared to another commonly used combination therapy regimen in the second-line HER2 positive metastatic gastric cancer setting,” said Dr Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “Results from our earlier research have led to approvals of ENHERTU in two regions for patients with HER2 positive metastatic gastric cancer and we are excited to continue our research in this patient population to further support our efforts to bring a new treatment option to more patients around the world.”
In DESTINY-Gastric04, patients will be randomised to receive either ENHERTU or ramucirumab/paclitaxel. The primary endpoint of DESTINY-Gastric04 is overall survival. Secondary endpoints include investigator assessed progression-free survival, objective response rate, duration of response, disease control rate, safety, pharmacokinetics and immunogenicity.
DESTINY-Gastric04 will enrol approximately 490 patients at multiple sites in Asia, Europe and South America.