FDA Approval Insights: Trastuzumab Deruxtecan in HER2+ Metastatic Gastric/GEJ Cancer

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Today, we had the pleasure of speaking with Kohei Shitara, MD, chief of the Department of Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan, to discuss the FDA approval of fam-trastuzumab deruxtecan-nxki (Enhertu) in HER2-positive metastatic gastric/gastroesophageal junction (GEJ) cancer.

On January 15, 2021, the FDA approved trastuzumab deruxtecan for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric/GEJ adenocarcinoma who have received a previous trastuzumab (Herceptin)-based regimen. The regulatory decision was based on data from the phase 2 DESTINY-Gastric01 trial in which trastuzumab deruxtecan induced a higher objective response rate compared with chemotherapy in patients with advanced, HER2-positive gastric or GEJ adenocarcinoma who had progressed following a trastuzumab-based treatment.

Trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate that utilizes a topoisomerase payload, Shitara explained. Moreover, the payload has good permeability that can elicit a bystander effect on HER2-negative cancer cells surrounding the target. As such, patients with heterogenous cancers, such as gastric cancer, may derive benefit from this agent, Shitara said.

In our exclusive interview, Shitara discussed the significance of the FDA approval of trastuzumab deruxtecan in HER2-positive gastric and GEJ adenocarcinoma and key efficacy and safety data that have been reported with the agent.