OnCo
trialsTrialPositive

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).

Outcomes

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In plain words
What these results mean for people, not percentages
494 people took part
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.

Overall survivalprimary
HR 0.7
T-DXd 6.4 mg/kg
14.7 mo
Ramucirumab + paclitaxel
11.4 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryT-DXd 6.4 mg/kg24614.7 months0.7link
Ramucirumab + paclitaxel24811.4 months
Replication
Consistent with DESTINY-Gastric01 (OS 12.5 vs 8.4 months vs chemotherapy, third line).

Connected

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