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A Chinese HER2 ADC cut the risk of progression by nearly 80% versus a pill-plus-chemotherapy standard, matching the scale of Enhertu's results.
HORIZON-Breast01, trial NCT05424835 sponsored by Jiangsu Hengrui and reported at ESMO 2025 and in Lancet Oncology in 2026, showed that the Chinese HER2 antibody-drug conjugate trastuzumab rezetecan cut the risk of progression by nearly eighty percent compared with pyrotinib plus capecitabine in HER2-positive metastatic breast cancer after trastuzumab and a taxane, matching the scale of trastuzumab deruxtecan's results. It randomised 366 patients in China and met its primary progression-free survival endpoint by blinded review at an interim analysis with a very large effect. OnCo links it to trastuzumab rezetecan and pyrotinib. The effect is comparable in magnitude to DESTINY-Breast03, but there is no head-to-head comparison with trastuzumab deruxtecan, which 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.
381 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (BICR)primary | Trastuzumab rezetecan | - | 30.6 months | 0.22 | - | link |
| Pyrotinib + capecitabine | - | 8.3 months |
Shares Pyrotinib, Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads).
Shares Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads), HER2-positive breast cancer.
Shares Pyrotinib, Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads).
Shares Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads), HER2-positive breast cancer.
Shares Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads), Antibody-drug conjugate (ADC).
Shares Trastuzumab rezetecan, Jiangsu Hengrui Pharmaceuticals, Topoisomerase-I inhibitors (and ADC payloads), HER2-positive breast cancer.