Dr. Ciombor on the FDA Approval of Trastuzumab Deruxtecan in HER2+ Metastatic Gastric Cancer

Kristen K. Ciombor, MD, MSCI, assistant professor of medicine, Division of Hematology/Oncology, Department of Medicine, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, discusses the FDA approval of fam-trastuzumab deruxtecan-nxki (Enhertu) in HER2-positive metastatic gastric cancer.

On January 15, 2021, the FDA approved trastuzumab deruxtecan for the treatment of patients with locally advanced or metastatic HER2-positive gastric/gastroesophageal junction (GEJ) cancer who received a prior trastuzumab (Herceptin)-based regimen. The regulatory decision was based on findings from the phase 2 DESTINY-Gastric01 trial in which the antibody-drug conjugate improved overall survival and induced a higher objective response rate compared with chemotherapy in this patient population.

Trastuzumab deruxtecan is a welcome addition to the gastric/GEJ cancer armamentarium, says Ciombor. However, as some patients will lose HER2 expression, routine biopsies are needed to determine whether the patient expresses the HER2 target and is still eligible to receive trastuzumab deruxtecan, Ciombor concludes.