NEW YORK – Daiichi Sankyo and AstraZeneca said on Friday that investigators have dosed the first HER2-positive, advanced gastric cancer patient in the Phase III DESTINY-Gastric04 trial of trastuzumab deruxtecan (Enhertu) versus ramucirumab (Eli Lilly's Cyramza) and chemotherapy.
The trial, which will take place across multiple sites in Asia, Europe, and South America, will randomize roughly 490 previously treated, HER2-positive, advanced gastric or gastroesophageal junction (GEJ) cancer patients to receive either trastuzumab or ramucirumab-chemo.
Researchers are primarily interested in whether trastuzumab deruxtecan improves overall survival compared to the chemotherapy-containing regimen in patients whose cancers have progressed on a prior trastuzumab (Genentech's Herceptin)-containing regimen and who have not received any additional systemic therapy. Secondary endpoints of the trial are progression-free survival, objective response rate, and duration of survival, among other outcomes.
In January, the US Food and Drug Administration approved Daiichi Sankyo and AstraZeneca's antibody drug conjugate for patients with advanced, HER2-positive gastric or GEJ cancer previously treated with a trastuzumab-containing regimen based on the results of the Phase II DESTINY-Gastric01 trial. Regulators in Japan have also approved the agent for this indication.