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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.
DESTINY-Breast05, trial NCT04622319 sponsored by Daiichi Sankyo and AstraZeneca and reported at ESMO 2025, showed that trastuzumab deruxtecan cut recurrence or death by more than half compared with trastuzumab emtansine in women with high-risk HER2-positive early breast cancer left with residual disease after pre-surgery treatment, replacing the KATHERINE standard. It randomised 1,635 women and met its primary invasive disease-free survival endpoint at an interim analysis with a large effect, at the cost of more interstitial lung disease, and the FDA approved the post-neoadjuvant indication in the second quarter of 2026 alongside the neoadjuvant DESTINY-Breast11 indication. OnCo links it to trastuzumab deruxtecan and trastuzumab emtansine, to trastuzumab brengitecan as a follower. Whether the lung toxicity is acceptable in a curative setting is the open question.
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 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 3-year invasive disease-free survivalprimary | T-DXd | - | 92.4% | 0.47 (0.34 to 0.66) | <0.0001 | link |
| T-DM1 | - | 83.7% |
Shares Can T-DXd alone cure early HER2-positive disease?, Early HER2-positive breast cancer, Daiichi Sankyo, Trastuzumab deruxtecan.
Shares Trastuzumab brengitecan, Trastuzumab emtansine, Early HER2-positive breast cancer, HER2-positive breast cancer.
Shares Trastuzumab emtansine, Early HER2-positive breast cancer, Topoisomerase-I inhibitors (and ADC payloads), HER2-positive breast cancer.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Daiichi Sankyo, Trastuzumab deruxtecan, Topoisomerase-I inhibitors (and ADC payloads), AstraZeneca.
Shares Trastuzumab brengitecan, Trastuzumab emtansine, HER2-positive breast cancer, 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).