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Clin Cancer Res: Results of the first clinical trial of HER2 bispecific antibody KN026 monotherapy for HER2+ metastatic breast cancer

 Last Update: 2021-12-24
 Source: Internet
 Author: User

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dunedin study

cancer biomark

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Breast cancer is the most common cancer in women worldwide
.
About 15-20% of patients have human epidermal factor receptor 2 (HER2/ERBB2) overexpression or amplification, which can benefit from HER2 targeted drug therapy

Breast cancer

KN026 is a new type of bispecific antibody that can simultaneously bind to two different epitopes of HER2
.
This is the first phase I trial conducted in humans to evaluate the safety/tolerability, pharmacokinetics, initial effect and potential prediction of KN026 as a single agent for HER2-positive metastatic breast cancer patients Biomarker activity

Recruited patients with HER2-positive metastatic breast cancer who had progressed after receiving anti-HER2 therapy and received intravenous KN026 monotherapy: 5 mg/kg (QW), 10 mg/kg (QW), 20 mg/kg (Q2W) or 30 mg/kg (Q3W)
.

Treatment-related side effects

A total of 63 patients were recruited
.
The most common treatment-related side effects are fever (23.

8%), risk (22.

The most common treatment-related side effects were fever (23.

Increased transaminase (22.

Best response to treatment

The results of the exposure response analysis support the use of 20 mg/kg (Q2W) or 30 mg/kg (Q3W) as the recommended phase 2 dose.
When treated with this dose, the objective response rate (ORR) of 57 patients reached 28.
1%, which was medium The progression-free survival (PFS) was 6.
8 months (95% CI 4.
2-8.
3)
.

The objective response rate (ORR) of 57 patients reached 28.
1%, and the median progression-free survival (PFS) was 6.
8 months (95% CI 4.
2-8.
3)
.
The objective response rate (ORR) of 57 patients reached 28.

1%, and the median progression-free survival (PFS) was 6.

Simultaneous amplification of HER2 and CDK12 is a potential biomarker for predicting a better response to KN026 treatment.

The HER2 bispecific antibody KN026 is well tolerated in patients with metastatic breast cancer, and its therapeutic effect is comparable to the dual treatment of trastuzumab and pertuzumab.

Original source:

Jian Zhang, Dongmei Ji, Li Cai, et al.

First-in-human HER2-targeted Bispecific Antibody KN026 for the Treatment of Patients with HER2-positive Metastatic Breast Cancer: Results from a Phase I Study in this message

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