EU Approves Fam-Trastuzumab Deruxtecan-nxki HER2+ Advanced Gastric Cancer

The European Commission has approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma who have previously been treated with a trastuzumab (Herceptin)–based regimen, according to a press release from developer AstraZeneca.¹

The regulatory decision was based on data from the phase 2 DESTINY-Gastric01 (NCT03329690)—assessing trastuzumab deruxtecan in HER2-expressing gastric cancer—and the phase 2 DESTINY-Gastric02 (NCT04014075)—analyzing trastuzumab deruxtecan in HER2-positive gastric cancer not eligible for surgical resection or that has spread.

Data from DESTINY-Gastric002 highlighted an objective response rate (ORR) of 41.8% by independent central review among patients treated with the agent, with a median duration of response (DOR) of 8.1 months.

Additionally, the DESTINY-Gastric001 trial, which focused primarily on patients in Japan and South Korea, identified an ORR of 40.5% with trastuzumab deruxtecan vs 11.3% with chemotherapy by independent central review. Moreover, the median duration of response was 11.3 months vs 3.9 months in the chemotherapy, respectively. This translated to a 41% reduction in risk of death in the experimental arm compared with the control arm (HR, 0.59; 95% CI, 0.39-0.88; P = .0097)

The FDA approved trastuzumab deruxtecan for the treatment of HER2-positive gastric cancers in January 2021 based on findings from the DESTINY-Gastric01 study.²

References

1. Enhertu approved in the EU for patients with previously treated HER2-positive advanced gastric cancer. News release. AstraZeneca. December 19, 2022. Accessed December 19, 2022. https://bit.ly/3YrEZ3E
2. FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas. News release. FDA. January 15, 2021. Accessed December 19, 2022. https://bit.ly/3FEsLw3