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The first trial of the HER2 antibody-drug conjugate in bowel cancer. Almost half the strongly HER2-positive tumours shrank, including some that had already failed other HER2 drugs.
DESTINY-CRC01 enrolled 78 treated patients into three cohorts by HER2 expression: cohort A (IHC 3+ or IHC 2+ and ISH-positive, 53 patients), cohort B (IHC 2+, ISH-negative, seven) and cohort C (IHC 1+, 18). In cohort A the confirmed objective response rate was 45.3 percent (95% CI 31.6 to 59.6) after a median 27.1 weeks. Grade 3 or worse events in at least a tenth of participants were decreased neutrophil count (22 percent) and anaemia (14 percent); five patients (6 percent) had adjudicated interstitial lung disease or pneumonitis, two of them fatal, the only treatment-related deaths. DESTINY-CRC02 then tested the lower 5.4 mg/kg dose (response 37.8 percent) which is the dose in the April 2024 tumour-agnostic HER2 IHC 3+ accelerated approval.
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.
86 treated.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Confirmed objective response rate (cohort A, HER2-positive)primary | Trastuzumab deruxtecan 6.4 mg/kg | 53 | 45.3 percent | - | - | link |
Shares DESTINY-CRC02, HER2-amplified colorectal cancer, Daiichi Sankyo, Trastuzumab deruxtecan.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares DESTINY-CRC02, MOUNTAINEER, HER2-amplified colorectal cancer, HER2.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), HER2.