NEW YORK – Daiichi Sankyo and AstraZeneca on Thursday said they have dosed the first HER2-positive gastric cancer patient in China in the Phase II DESTINY-Gastric06 trial of trastuzumab deruxtecan (Enhertu).
Specifically, the single-arm trial is evaluating the HER2-targeting antibody drug conjugate as a third-line treatment for roughly 75 patients with HER2-positive locally advanced or metastatic gastric cancer or gastroesophageal junction cancer. Patients in the trial must have previously received a fluoropyrimidine and platinum-containing chemotherapy agent.
The primary endpoint of the DESTINY-Gastric06 trial — which is taking place at multiple sites throughout China — is objective response rate. Secondary endpoints include progression-free survival, duration of response, disease control rate, and overall survival, among other safety and efficacy endpoints.
Early this year, 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 (Genentech's Herceptin)-containing regimen based on the results of the Phase II DESTINY-Gastric01 trial. Regulators in Japan have also approved the agent for this indication.
Several months ago, the partnered firms also began evaluating trastuzumab deruxtecan in the Phase III DESTINY-Gastric04 trial, which involves HER2-positive gastric and GEJ cancer patients previously treated with a trastuzumab regimen but not systemic therapy.
In a statement, Gilles Gallant, Daiichi Sankyo's senior VP and global head of oncology development, said that the firm anticipates that the new DESTINY-Gastric06 trial will support efforts to bring the agent to patients and providers in China.