Efficacy and Safety of Neoadjuvant TQB2102 in Locally Advanced or Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: A Randomized, Open-Label, Multicenter, Phase II Trial.

patients_and_methods

This randomized, open-label, multicenter, phase II study (ClinicalTrials.gov identifier: NCT06198751) enrolled HER2-positive patients with stage II and III disease.

这项随机、开放标签、多中心的II期研究（ClinicalTrials.gov注册号：NCT06198751）招募了II期和III期的HER2阳性患者。

Patients were stratified by hormone receptor status and randomly assigned (1:1) to receive 6.0 mg/kg once every 3 weeks of TQB2102 for six (cohort 1) or eight cycles (cohort 2) or 7.5 mg/kg once every 3 weeks for six (cohort 3) or eight cycles (cohort 4).

患者根据激素受体状态进行分层，并按1:1的比例随机分配，接受每3周一次6.0 mg/kg的TQB2102治疗，持续六个（第1组）或八个周期（第2组），或接受每3周一次7.5 mg/kg的TQB2102治疗，持续六个（第3组）或八个周期（第4组）。

The primary end point was total pathologic complete response (tpCR) rate across all four cohorts (n = 26 per cohort).

主要终点是所有四个队列（每队列n = 26）的总病理完全缓解（tpCR）率。

When the lower limit of the 90% CI (Clopper-Pearson exact binomial test) for tpCR rate exceeded 40%, efficacy was considered better than that of the historical control.

当tpCR率的90%置信区间（Clopper-Pearson精确二项检验）的下限超过40%时，疗效被认为优于历史对照组。

Results

Between February 5, 2024, and September 24, 2024, 104 patients were enrolled, with 26 patients in each cohort.

从2024年2月5日到2024年9月24日，共有104名患者被纳入研究，每个队列有26名患者。

The tpCR rates were 57.7% (15 of 26 [90% CI, 43.2 to 71.3]; P = .04) for cohort 1, 76.9% (20 of 26 [90% CI, 62.3 to 87.6]; P < .01) for cohort 2, 61.5% (16 of 26 [90% CI, 46.5 to 74.8]; P = .02) for cohort 3, and 69.2% (18 of 26 [90% CI, 54.6 to 81.3]; P < .01) for cohort 4.

各队列的完全病理缓解（tpCR）率分别为：队列1为57.7%（15/26，90%置信区间[CI]，43.2至71.3；P = .04），队列2为76.9%（20/26，90% CI，62.3至87.6；P < .01），队列3为61.5%（16/26，90% CI，46.5至74.8；P = .02），队列4为69.2%（18/26，90% CI，54.6至81.3；P < .01）。

The incidencerates of grade ≥3 treatment-related adverse events were 23.1% (6 of 26) for cohort 1, 30.8% (8 of 26) for cohort 2, 30.8% (8 of 26) for cohort 3, and 26.9% (7 of 26) for cohort 4.

与治疗相关的3级或更高级别不良事件的发生率分别为：队列1为23.1%（6/26），队列2为30.8%（8/26），队列3为30.8%（8/26），队列4为26.9%（7/26）。

No treatment-related deaths occurred in any groups.

在任何组中都没有发生与治疗相关的死亡事件。

Conclusions

To our knowledge, this was the first study to report the efficacy and safety of the bispecific HER2-directed ADC TQB2102 in the neoadjuvant setting for HER2-positive breast cancer.

据我们所知，这是首个报告双特异性HER2导向的ADC TQB2102在新辅助治疗HER2阳性乳腺癌中的疗效和安全性的研究。

TQB2102 showed robust activity and was well-tolerated.

TQB2102 显示出显著的疗效并具有良好的耐受性。