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DESTINY-Gastric01 showed that trastuzumab deruxtecan shrank tumours far more often than standard chemotherapy, and helped people live longer, in HER2-positive stomach cancer that had already progressed on trastuzumab.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
233 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response (independent central review)primary | Trastuzumab deruxtecan | 125 | 51% | - | <0.001 | link |
| Physician's choice chemotherapy (irinotecan or paclitaxel) | 62 | 14% | ||||
| Overall survival | Trastuzumab deruxtecan | 125 | 12.5 months | 0.59 (0.39 to 0.88) | 0.01 | link |
| Physician's choice chemotherapy (irinotecan or paclitaxel) | 62 | 8.4 months |
Shares DESTINY-Gastric01: trastuzumab deruxtecan in previously treated HER2-positive gastric cancer, HER2-positive gastric cancer, Daiichi Sankyo, Trastuzumab deruxtecan and the tag subtype-trials.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca and the tag subtype-trials.
Shares HER2-positive gastric cancer, Paclitaxel / nab-paclitaxel, Gastric & gastro-oesophageal junction cancer, Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares Kohei Shitara, Gastric & gastro-oesophageal junction cancer and the tag subtype-trials.
Shares HER2-positive gastric cancer, Gastric & gastro-oesophageal junction cancer and the tag subtype-trials.
Shares Paclitaxel / nab-paclitaxel, Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares AstraZeneca and the tag subtype-trials.