DESTINY-Gastric04
The first randomised proof that a HER2 drug beats standard chemotherapy in second-line stomach cancer: Enhertu added about three months of life.
OS 14.7 vs 11.4 months (HR 0.70); PFS 6.7 vs 5.6 months (ASCO 2025 plenary, NEJM). Confirms the accelerated approval from DESTINY-Gastric01 (Asia) and DESTINY-Gastric02 (West). Grade ≥3 treatment-related events 68% vs 74%; ILD requires monitoring.
Setting
Second-line HER2-positive gastric/GEJ cancer after trastuzumab: T-DXd vs ramucirumab + paclitaxel
Phase
Phase 3
Sponsor
Daiichi Sankyo / AstraZeneca
Registry
Headline result
OS 14.7 vs 11.4 months, HR 0.70.
Reported
2025
Enrolled
494
Replication
Consistent with DESTINY-Gastric01 (OS 12.5 vs 8.4 months vs chemotherapy, third line).
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 14.7 vs 11.4 months with T-DXd 6.4 mg/kg compared with Ramucirumab + paclitaxel; about 3.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 30 percent lower chance of the event at any given time (hazard ratio 0.7).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Second-line HER2-positive gastric/GEJ cancer after trastuzumab: T-DXd vs ramucirumab + paclitaxel. 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.
494 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | T-DXd 6.4 mg/kg | 246 | 14.7 months | 0.7 | — | link |
| Ramucirumab + paclitaxel | 248 | 11.4 months |
Replication
Consistent with DESTINY-Gastric01 (OS 12.5 vs 8.4 months vs chemotherapy, third line).