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The phase III APEX-Breast01 trial reported median progression-free survival of 16.4 months with the investigational HER2-targeting ADC TQB2102, compared with 5.5 months with chemotherapy, among patients with HER2-low metastatic breast cancer. The study was conducted in China, and overall-survival findings are preliminary; TQB2102 is not approved anywhere.
An investigational HER2-targeting antibody-drug conjugate, rolditamig deuderuxtecan (TQB2102), extended median progression-free survival to 16.4 months, compared with 5.5 months for chemotherapy, in the China-only phase III APEX-Breast01 trial of HER2-low recurrent or metastatic breast cancer. The findings, reported at the 2026 European Society for Medical Oncology congress, show a substantial delay in disease progression in this trial, but survival results remain preliminary and the drug is not approved anywhere.
Investigators randomized 543 patients to TQB2102 or investigator-selected chemotherapy. Participants had HER2-low disease, defined as immunohistochemistry (IHC) 1 or IHC 2+ with a negative in-situ hybridization test, and had not received chemotherapy for metastatic disease. The trial included 461 patients with hormone receptor-positive cancer and 82 with hormone receptor-negative cancer; its primary endpoint was progression-free survival, assessed by independent review in the hormone receptor-positive group.
At a prespecified interim analysis, after 216 progression-free survival events, the hazard of progression or death was 71% lower with TQB2102 than with chemotherapy (95% confidence interval 0.22-0.39; P<0.0001). Six-month progression-free survival was 81.4% versus 45.9%. Investigator-assessed results were consistent, with a reported 69% reduction in the hazard. The objective response rate in the overall HER2-low population was 68.8% with TQB2102 and 31% with chemotherapy.
Overall-survival findings were not mature. After a median follow-up of 8.6 months, the preliminary analysis found that 7% of patients in the TQB2102 group and 13.3% in the chemotherapy group in the hormone receptor-positive subgroup had died, corresponding to a reported 53% reduction in the hazard of death. The event rates also favored TQB2102 in the hormone receptor-negative subgroup, but these early figures do not establish a definitive survival benefit.
A Larger Delay in Disease Progression
The reported median progression-free survival difference could matter to patients whose cancer has returned or spread and who have not yet received chemotherapy in the metastatic setting. In this trial, TQB2102 was associated with a longer period before disease progression or death than the chemotherapy options used by investigators. The response-rate results also favored the ADC, though they do not by themselves show how long responses last or whether patients live longer.
The findings are relevant to an increasingly active field of HER2-targeting ADCs. However, the results do not establish that TQB2102 is superior to other ADCs: APEX-Breast01 compared it with chemotherapy, not with another HER2-targeting drug. Its China-only enrollment also limits how directly the findings can be applied to patients and treatment settings elsewhere. Further evidence, including mature survival data and regulatory review, will be needed before its role in care is clear.
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How TQB2102 Differs From Existing ADCs
TQB2102 is described by the trial presenter as a HER2 biparatopic ADC: its antibody binds two non-overlapping sites on HER2. Presenter Shusen Wang of Sun Yat-sen University Cancer Center said this design may promote receptor crosslinking and internalization. That is a proposed pharmacological distinction, not proof that the design gives patients a clinical advantage over other ADCs.
The APEX-Breast01 population had received a median of two previous lines of systemic therapy, and more than 60% had three or more metastatic sites. The trial follows earlier phase I results that showed a 58% objective response rate, according to the report. TQB2102 has not been approved in any country. The supplied report says the FDA granted it breakthrough status but does not provide the date or further details about that designation.
“Rolditamig deuderuxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS and a clear trend toward OS benefit versus chemotherapy in patients with HER2-low recurrent or metastatic breast cancer.”
— Shusen Wang, MD, Sun Yat-sen University Cancer Center, presenting the results
Survival and Safety Need More Follow-Up
The overall-survival analysis is preliminary, based on a median follow-up of 8.6 months. The reported hazard reductions and death proportions may change with longer follow-up, and the available results do not confirm that TQB2102 helps patients live longer. The supplied report does not give mature median overall-survival estimates.
Safety also needs to be weighed against the efficacy findings. Although Wang described the overall profile as manageable and reported a low incidence of interstitial lung disease, grade 3 or higher treatment-related adverse events occurred in 69.1% of patients receiving TQB2102, compared with 42.4% receiving chemotherapy. Treatment-related adverse-event discontinuation was 1.5% in both groups, and hematologic events were the most common in each arm. The report does not provide the full breakdown of individual adverse events here.
It is also not clear from the supplied results how the findings will translate outside China, how the drug will compare with current ADC options, or what regulatory steps and timelines may follow. The report’s mention of FDA breakthrough status does not establish approval or availability.
Mature Data and Regulatory Review
Researchers will need to continue following participants to clarify overall survival, the durability of responses and longer-term safety. Additional trial details and peer-reviewed reporting could also help clinicians assess how the results apply to different patient groups. No approval decision or launch timeline is established by the information reported here.
As Pistilli said, a comparison against the relevant standard of care is needed to determine how TQB2102 performs relative to other ADCs; APEX-Breast01 compared the drug with chemotherapy. Future studies may also help identify which patients are most likely to benefit and how ADCs should be sequenced. Until further evidence and regulatory decisions are available, TQB2102 remains an investigational treatment.
Key Questions
What is TQB2102?
TQB2102, also called rolditamig deuderuxtecan, is an investigational antibody-drug conjugate designed to target HER2. Its antibody is described as biparatopic because it binds two non-overlapping sites on the HER2 protein.
How much longer was progression-free survival in APEX-Breast01?
Median progression-free survival was 16.4 months with TQB2102 and 5.5 months with chemotherapy. The result came from a prespecified interim analysis in the China-only phase III trial.
Does the trial prove TQB2102 improves overall survival?
No. The reported overall-survival findings were preliminary, after a median follow-up of 8.6 months. Longer follow-up is needed to determine whether the early differences persist.
Is TQB2102 approved for breast cancer?
No. The report states that TQB2102 has not been approved anywhere. It describes trial results, not an authorization for routine use.
How did adverse events compare with chemotherapy?
Grade 3 or higher treatment-related adverse events were reported in 69.1% with TQB2102 and 42.4% with chemotherapy. Discontinuation because of treatment-related adverse events was 1.5% in each group; the report says hematologic events were most common in both arms.
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