#ESMO2026 LBA27: Phase 3 APEX-Breast01 — 🇨🇳CTTQ's TQB2102 (biparatopic HER2 ADC) vs chemo in HER2-low r/m breast cancer.
Developed by CTTQ; NDA submitted in China.
543 patients (no prior advanced chemo) randomized to TQB2102 7.5 mg/kg Q3W or TPC (capecitabine/paclitaxel/nab-paclitaxel).
Results (data cutoff May 31, 2026):
• PFS: 16.4 vs 5.5 mo (HR 0.29, p<0.0001) in both HR+/HER2-low and all HER2-low
• Clear OS benefit trend (data immature)
• ORR: ~67% vs ~31%
Safety: Manageable. Grade ≥3 neutropenia most common. TRAE discontinuation 1.5% each arm. ILD in 2.2% (mostly Grade 1–2).
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APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) - Results from a randomized phase 3 study
https://esmocongress.esmo.orgSource: Minhua Chu · x.com