Trastuzumab rezetecan significantly improved progression-free and overall survival compared to pyrotinib plus capecitabine in patients with HER2-positive metastatic breast cancer who had prior treatment with trastuzumab and taxanes. The median progression-free survival was 30.6 months with trastuzumab rezetecan versus 8.3 months with pyrotinib plus capecitabine. Trastuzumab rezetecan also demonstrated a distinct safety profile with a low incidence of interstitial lung disease.
Study
|
Randomized, open-label, multicentre, phase 3 study [NCT05424835] |
| HER2-positive metastatic breast cancer previously treated with trastuzumab and taxane |
| Trastuzumab rezetecan (n=142) vs Pyrotinib plus capecitabine (n=145)
|
Efficacy
|
ORR: 81.7% [74.3-87.7] vs 55.9% [47.4-64.1] |
| mPFS: 30.6 mos [16.8-NR] vs 8.3 mos [6.9-11.0] (HR 0.22 [0.15-0.34]) |
| mDOR: 27.8 mos [17.8-NR] vs 10.9 mos [8.3-NR] |
| mOS: NR vs NR (HR 0.31 [0.14-0.69])
|
Safety
|
Grade >=3 AE: neutropenia (54% vs 9%), thrombocytopenia (11% vs 1%), pneumonia (3% vs 1%), interstitial lung disease (1% vs 0%) |
| Serious adverse events: 13% vs 12%
|
Lancet Oncol 2026;27:929-40
http://doi.org/10.1016/S1470-2045(26)00193-2
Reviewed by Ulas D. Bayraktar, MD on Aug 19, 2026
