NEW YORK – AstraZeneca said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended Enhertu (trastuzumab deruxtecan) for patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have previously received trastuzumab.
The committee recommended Enhertu, which AstraZeneca markets with Daiichi Sankyo, based on data from the DESTINY-Gastric01 and DESTINY-Gastric02 Phase II trials. In DESTINY-Gastric01, patients from Japan and South Korea who had progressed on two prior regimens of chemotherapy and trastuzumab had an overall response rate of 51.3 percent on Enhertu compared to 14.3 percent on chemotherapy. Their median overall survival was 12.5 months versus 8.9 months, respectively.
The open-label DESTINY-Gastric02 trial focused on patients with HER2-positive gastric cancer who had progressed during or after a treatment regimen containing trastuzumab. In that trial, conducted in North America and Europe, patients treated with Enhertu had a confirmed objective response rate of 41.8 percent, a median duration of response of 8.1 months, and overall survival of 12.1 months.
The US Food and Drug Administration relied on DESTINY-Gastric01 data when approving Enhertu last year in this previously treated gastric cancer setting.
About 20 percent of gastric cancer patients are HER2-positive. The recommended first-line therapy for these cancers is combination trastuzumab plus chemotherapy. Treatment options are limited for patients who progress after first-line therapy.