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Inetetamab plus camrelizumab and utidelone for pretreated HER2-positive advanced breast cancer: a prospective,
Huimin Lv1, Tao Sun2, Xiaoling Ling3
1Department of Breast Disease, Henan Breast Cancer Center, the Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
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.
Insights
This study shows that a combination of inetetamab, camrelizumab, and utidelone is effective for HER2-positive metastatic breast cancer (MBC) that has not responded to prior treatments. The novel therapy demonstrated promising progression-free survival and a manageable safety profile in heavily pretreated patients.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Efficacy and safety of combined anti-HER2 therapy, immune checkpoint inhibitors, and chemotherapy for HER2-positive advanced breast cancer (MBC) post-standard therapy failure is unknown.
- A novel combination therapy including inetetamab (anti-HER2), camrelizumab (anti-PD-1), and utidelone (microtubule inhibitor) was evaluated in treatment-refractory HER2-positive MBC.
- The study was registered as NCT04681287.
Purpose of the Study:
- To evaluate the efficacy and safety of a novel combination therapy in patients with HER2-positive MBC who have progressed on standard HER2-directed therapies.
- To determine the 3-month progression-free survival (PFS) rate as the primary endpoint in this heavily pretreated population.
Main Methods:
- A single-arm, multicentre, phase 2 trial (ICU study) conducted across five centers in China.
- Enrolled patients with HER2-positive MBC who had prior progression on trastuzumab and tyrosine kinase inhibitors (TKIs).
- Assessed the primary endpoint of 3-month PFS rate in the per-protocol population.
Main Results:
- A total of 48 patients with a median of three prior systemic therapies for advanced disease were enrolled.
- The 3-month PFS rate was 71.67% (95% CI: 59.7-85.9) in 46 evaluable patients.
- The most frequent treatment-emergent adverse events were peripheral neuropathy (87.2%) and reactive cutaneous capillary endothelial proliferation (57.4%), with no grade 4 or 5 events observed.
Conclusions:
- The combination of inetetamab, camrelizumab, and utidelone showed promising efficacy in heavily pretreated HER2-positive MBC patients.
- The safety profile of this novel regimen was manageable.
- These findings support further investigation of this combination in randomized controlled trials for treatment-refractory HER2-positive MBC.
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