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DESTINY-Lung01 showed that the antibody-drug conjugate trastuzumab deruxtecan shrank tumours in more than half of people whose lung cancer carried a HER2 mutation, which led to the first approved HER2-targeted treatment for lung cancer.
DESTINY-Lung01 was a two-cohort phase 2 study of trastuzumab deruxtecan, an antibody-drug conjugate that delivers a topoisomerase I inhibitor to HER2-expressing cells, in metastatic non-small-cell lung cancer that had progressed on standard therapy. One cohort enrolled HER2-mutant tumours and the other HER2-overexpressing tumours.
In the HER2-mutant cohort the drug produced responses in a majority of patients with durable disease control, including in the brain. Interstitial lung disease was the toxicity that needed monitoring. The result led to accelerated approval in the United States in August 2022 for HER2-mutant non-small-cell lung cancer after prior systemic therapy, the first HER2-directed approval in lung cancer. The HER2-overexpressing cohort showed lower activity.
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.
181 enrolled.
95% CI 44 to 65; median follow-up 13.1 months
SourceFatal in 2 patients
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response (independent central review), HER2-mutant cohortprimary | Trastuzumab deruxtecan 6.4 mg/kg | 91 | 55% | - | - | link |
| Duration of response | Trastuzumab deruxtecan 6.4 mg/kg | 91 | 9.3 months | - | - | link |
| Progression-free survival | Trastuzumab deruxtecan 6.4 mg/kg | 91 | 8.2 months | - | - | link |
| Overall survival | Trastuzumab deruxtecan 6.4 mg/kg | 91 | 17.8 months | - | - | link |
| Adjudicated drug-related interstitial lung disease | Trastuzumab deruxtecan 6.4 mg/kg | 91 | 26% | - | - | link |
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca and the tag subtype-trials.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca and the tag subtype-trials.
Shares Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC) and the tag subtype-trials.
Shares AstraZeneca, Lung cancer (all types), Non-small-cell lung cancer and the tag subtype-trials.
Shares Lung cancer (all types), Non-small-cell lung cancer and the tag subtype-trials.
Shares Lung cancer (all types), Non-small-cell lung cancer and the tag subtype-trials.
Shares AstraZeneca and the tag subtype-trials.
Shares Antibody-drug conjugate (ADC) and the tag subtype-trials.