Kohei Shitara, MD, discusses the FDA approval of fam-trastuzumab deruxtecan-nxki in HER2-positive metastatic gastric/gastroesophageal junction cancer.
Kohei Shitara, MD, chief, Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan, discusses 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 (ADC) that utilizes a topoisomerase payload, Shitara explains. 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 says.
Previously, in September 2020, the Japanese Ministry of Health, Labor, and Welfare approved trastuzumab deruxtecan for the treatment of patients with HER2-positive unresectable advanced or recurrent gastric cancer that has progressed following chemotherapy. The FDA approval is a welcome addition to the limited armamentarium for patients with metastatic gastric cancer and should become a standard of care in the space, concludes Shitara.