DESTINY-CRC02
Enhertu shrank about four in ten heavily pretreated HER2-positive bowel cancers, including ones that had already stopped responding to other HER2 drugs.
Confirmed ORR 37.8% at 5.4 mg/kg and 27.5% at 6.4 mg/kg (Lancet Oncology 2024); responses regardless of prior HER2 therapy or RAS status. Supported the 2024 tumour-agnostic HER2 IHC3+ accelerated approval, which covers CRC at 5.4 mg/kg.
Setting
Pretreated HER2-positive metastatic colorectal cancer: T-DXd 5.4 vs 6.4 mg/kg
Phase
Phase 2
Sponsor
Daiichi Sankyo / AstraZeneca
Registry
Headline result
ORR 37.8% (5.4 mg/kg).
Reported
2023
Enrolled
122
Replication
Consistent with DESTINY-CRC01 (ORR 45% in IHC3+/ISH+).
In plain words
What these results mean for people, not percentages
Objective response rateprimaryresponse endpoint
- 37.8 vs 27.5 out of 100 had their tumour shrink with T-DXd 5.4 mg/kg compared with T-DXd 6.4 mg/kg; 10.3 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: Pretreated HER2-positive metastatic colorectal cancer: T-DXd 5.4 vs 6.4 mg/kg. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
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.
122 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response rateprimary | T-DXd 5.4 mg/kg | 82 | 37.8 percent | — | — | link |
| T-DXd 6.4 mg/kg | 40 | 27.5 percent |
Replication
Consistent with DESTINY-CRC01 (ORR 45% in IHC3+/ISH+).