Dr. Shitara on the Rationale for the DESTINY-Gastric04 Trial in HER2+ Gastric Cancers

Kohei Shitara, MD, chief, Department of Gastrointestinal Oncology, the National Cancer Center Hospital East, in Kashiwa, Japan, discusses the rationale for the phase 3 DESTINY-Gastric04 trial (NCT04704934) in patients with HER2-positive gastric cancer or gastro-esophageal junction (GEJ) adenocarcinoma.

The randomized, open-label study will evaluate the efficacy and safety of fam-trastuzumab deruxtecan-nxki (Enhertu) compared with the standard of care in patients who have progressed on a trastuzumab (Herceptin)-containing regimen.

Based on the phase 2 DESTINY-Gastric01 trial (NCT03329690), in both 2020 and 2021, trastuzumab deruxtecan was approved for the treatment of metastatic HER2-positive gastric cancer in the Japan and in the United States, respectively, Shitara says. However, the approval in Japan only covered an indication for patients with unresectable advanced or recurrent gastric cancer that has progressed following chemotherapy, Shitara adds. Though the FDA approval covered treatment in the second-line setting, there is currently no direct comparison between trastuzumab deruxtecan and standard of care, Shitara explains.

A confirmatory DESTINY-Gastric04 trial will compare trastuzumab deruxtecan to the current standard of care, and the trial is currently enrolling, Shitara concludes.