DESTINY-Gastric01

DESTINY-Gastric01 was an open-label randomised phase 2 trial in Japan and South Korea. Patients with HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose disease had progressed after at least two regimens including trastuzumab were randomised two to one to trastuzumab deruxtecan or to the physician's choice of irinotecan or paclitaxel. The primary endpoint was objective response by independent review. Exploratory cohorts enrolled HER2-low tumours.

The response rate was substantially higher with trastuzumab deruxtecan and overall survival was longer than with chemotherapy. Interstitial lung disease and myelosuppression were the notable toxicities. The result led to approval in the United States in January 2021 for HER2-positive gastric cancer after a trastuzumab-based regimen, the first antibody-drug conjugate for the disease.