Scholarlink

Background <p>The efficacy and safety of anti-HER2 therapy and immune checkpoint inhibitors combined with chemotherapy to treat HER2-positive advanced breast cancer that has failed standard HER2-directed therapies is unknown. This study evaluated the efficacy and safety of a novel, fully China-developed combination therapy—comprising inetetamab (an anti-HER2 monoclonal antibody), camrelizumab (an anti-PD-1 antibody), and utidelone (a microtubule inhibitor)—in this treatment-refractory population.</p> Methods <p>The ICU study (NCT04681287) was a single-arm, multicentre, phase 2 trial conducted at five centres in China. Patients with HER2-positive MBC who had experienced progression on prior trastuzumab and TKIs were enrolled. The primary endpoint was the 3-month progression-free survival (PFS) rate in the per-protocol population.</p> Results <p>A total of 48 patients with a median of three previous systemic therapies for advanced disease (range, 1–4) were enrolled (median follow-up duration 43.0&#xa0;months). The 3-month PFS rate in 46 patients was 71.67% (95% CI: 59.7–85.9). The most common any-grade treatment-emergent adverse events (TEAEs) were peripheral neuropathy (87.2%, two events were grade 3) and reactive cutaneous capillary endothelial proliferation (57.4%, all grade 1–2). There were no grade 4 or 5 TEAEs.</p> Conclusions <p>The combination of inetetamab, camrelizumab, and utidelone demonstrated promising efficacy and a manageable safety profile in heavily pretreated patients with HER2-positive MBC. These findings support this regimen as a viable treatment option in this setting and warrant further investigation in randomized controlled trials.</p> Trial registration <p>The study was registered at ClinicalTrials.gov with the identifier NCT04681287.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Inetetamab plus camrelizumab and utidelone for pretreated HER2-positive advanced breast cancer: a prospective, single-arm, phase 2 study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月27日

查看全文
  • Huimin Lv,
  • Tao Sun,
  • Xiaoling Ling,
  • Xinlan Liu,
  • Jin Yang,
  • Mengwei Zhang,
  • Limin Niu,
  • Shumin Chen,
  • Zhenzhen Liu,
  • Chengzheng Wang,
  • Huihui Sun,
  • Jing Wang,
  • Huiai Zeng,
  • Shengnan Zhao,
  • Lanwei Guo,
  • Yajing Feng,
  • Zhiqing Zhang,
  • Qingxin Xia,
  • Rongguo Qiu,
  • Min Yan

摘要

Background

The efficacy and safety of anti-HER2 therapy and immune checkpoint inhibitors combined with chemotherapy to treat HER2-positive advanced breast cancer that has failed standard HER2-directed therapies is unknown. This study evaluated the efficacy and safety of a novel, fully China-developed combination therapy—comprising inetetamab (an anti-HER2 monoclonal antibody), camrelizumab (an anti-PD-1 antibody), and utidelone (a microtubule inhibitor)—in this treatment-refractory population.

Methods

The ICU study (NCT04681287) was a single-arm, multicentre, phase 2 trial conducted at five centres in China. Patients with HER2-positive MBC who had experienced progression on prior trastuzumab and TKIs were enrolled. The primary endpoint was the 3-month progression-free survival (PFS) rate in the per-protocol population.

Results

A total of 48 patients with a median of three previous systemic therapies for advanced disease (range, 1–4) were enrolled (median follow-up duration 43.0 months). The 3-month PFS rate in 46 patients was 71.67% (95% CI: 59.7–85.9). The most common any-grade treatment-emergent adverse events (TEAEs) were peripheral neuropathy (87.2%, two events were grade 3) and reactive cutaneous capillary endothelial proliferation (57.4%, all grade 1–2). There were no grade 4 or 5 TEAEs.

Conclusions

The combination of inetetamab, camrelizumab, and utidelone demonstrated promising efficacy and a manageable safety profile in heavily pretreated patients with HER2-positive MBC. These findings support this regimen as a viable treatment option in this setting and warrant further investigation in randomized controlled trials.

Trial registration

The study was registered at ClinicalTrials.gov with the identifier NCT04681287.