Analyzing the DESTINY-Gastric01 Trial for Gastric or GEJ Adenocarcinoma

Manish A. Shah, MD, director of the Gastrointestinal Oncology Program at Weill Cornell Medicine, chief of Solid Tumor Service, and codirector of the Center for Advanced Digestive Disease at New York-Presbyterian Hospital, discusses the design and efficacy of the DESTINY-Gastric01 trial of trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Shah found this phase 2 study to be exciting to see in this setting. Patients on DESTINY-Gastric01 were randomized 2:1 to DS-8201, a novel antibody drug conjugate, versus standard chemotherapy, which was either paclitaxel or irinotecan.

There was a statistically significant overall response rate in this trial of about 50% in patients who received DS-8201, with 11 complete responses and 50 partial responses. The median overall survival (OS) was also statistically significant at 12.5 months compared with 8.4 months for DS-8201 versus chemotherapy, respectively (HR, 0.59; 95% CI, 0.39-0.88; P =.0097). The 12-month OS rate was 52.1% with DS-8201 and 28.9% with chemotherapy. Based on the data, there is excitement about this drug, according to Shah. A more global follow-up study is currently being conducted.

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