APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) - Results from a randomized phase 3 study

APEX-Breast01

Patient / Population Intervention / Exposure Comparison Outcome

In patients with HR-positive, HER2-low recurrent or metastatic breast cancer, TQB2102 improved progression-free survival by blinded independent review compared with physician's choice chemotherapy.

N

543patients

Design

Phase 3 trial randomising patients 1:1 to TQB2102 or treatment of physician's choice (capecitabine, paclitaxel or nab-paclitaxel), in HER2-low recurrent or metastatic breast cancer without prior chemotherapy for advanced disease. HR+ patients had progressed after at least one line of endocrine therapy for metastatic disease, and HR- patients had CPS<1 or unknown status (NCT06561607).

Endpoint

Progression-free survival per blinded independent review committee in HR+/HER2-low patients.

ResultMedian PFS by BIRC in HR+/HER2-low patients 16.4 mo with TQB2102 vs 5.5 mo with physician's choice chemotherapy (HR 0.29, 95% CI 0.22-0.39; p<0.0001). Key secondary PFS in all HER2-low patients 16.4 mo vs 5.5 mo (HR 0.29, 95% CI 0.22-0.38; p<0.0001). Immature OS HR 0.47 (95% CI 0.26-0.87) in HR+ and 0.44 (95% CI 0.25-0.79) in all HER2-low patients. ORR by BIRC in HR+ patients 66.7% vs 31.3%. Grade ≥3 neutrophil count decreased 30.1% vs 23.3% and WBC decreased 21.6% vs 14.0%. TRAEs led to discontinuation in 1.5% in each group. TQB2102-related interstitial lung disease in 6 patients (2.2%; grade 3, 1.1%).

Wang S, Zhang Q, Shi Y, et al. Presented at ESMO Congress 2026, abstract LBA27, 23 October. Not yet published.

Discussion & critique

In this phase 3 trial, TQB2102 gave a large and statistically significant PFS gain over single-agent chemotherapy, and PFS was assessed by a blinded independent review committee. These are interim results. OS is immature and is reported only as hazard ratios, without P values or medians, and the upper confidence limit for median PFS in the TQB2102 arm could not be estimated. The abstract does not say whether patients or investigators were blinded to treatment, and the HR- subgroup, with 41 patients per arm, is too small to support firm conclusions. Interstitial lung disease occurred in 2.2% of patients, and the study was funded by Chia Tai Tianqing Pharmaceutical Group, which employs several of the authors.