DESTINY-Breast05
Enhertu cut recurrence or death by more than half compared with Kadcyla in women with cancer left after pre-surgery treatment, replacing the KATHERINE standard.
Interim analysis (ESMO 2025, LBA1): 3-year iDFS 92.4% vs 83.7%, HR 0.47 (P<0.0001). More ILD with T-DXd. FDA approved the post-neoadjuvant indication in Q2 2026 alongside the neoadjuvant DESTINY-Breast11 indication.
Setting
High-risk HER2+ early breast cancer with residual invasive disease after neoadjuvant therapy: T-DXd vs T-DM1
Phase
Phase 3
Sponsor
Daiichi Sankyo / AstraZeneca
Registry
Headline result
3-year iDFS 92.4% vs 83.7%, HR 0.47.
Reported
2025
Enrolled
1635
Replication
Consistent with DESTINY-Breast03 (T-DXd vs T-DM1 in metastatic disease, PFS HR 0.33).
In plain words
What these results mean for people, not percentages
3-year invasive disease-free survivalprimarysurrogate endpoint
- 92.4 vs 83.7 out of 100 alive without the cancer coming back at 3 years with T-DXd compared with T-DM1; 8.7 more per 100.
- Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 53 percent lower chance of the event at any given time (hazard ratio 0.47, likely range 0.34 to 0.66).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: High-risk HER2+ early breast cancer with residual invasive disease after neoadjuvant therapy: T-DXd vs T-DM1. 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.
1,635 participants enrolled.
3-year invasive disease-free survivalprimary
HR 0.47 (0.34–0.66) · p <0.0001
T-DXd92.4 of 100
T-DM183.7 of 100
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 3-year invasive disease-free survivalprimary | T-DXd | — | 92.4% | 0.47 (0.34–0.66) | <0.0001 | link |
| T-DM1 | — | 83.7% |
Replication
Consistent with DESTINY-Breast03 (T-DXd vs T-DM1 in metastatic disease, PFS HR 0.33).