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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | anbenitamab (KN026) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
Excerpt:
...- Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing....
Trial ID:
Source:
Title:
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
Excerpt:
...- Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive;...
Trial ID:
More C2 evidence
Source:
Title:
Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
Excerpt:
...- Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH);...
Trial ID:
Less C2 evidence
Source:
Title:
247P - KN026 in combination with docetaxel as neoadjuvant treatment for HER2+ early or locally advanced breast cancer (BC): A single-arm, multicenter, phase II study
Published date:
10/16/2023
Excerpt:
In FAS, tpCR rate was 56.7% (17/30, 95% CI: 37.43%-74.53%), bpCR rate was 60% (18/30, 95% CI:40.60%-77.34%), ORR was 90.0% (27/30, 95% CI: 73.47%-97.89%)….KN026 plus docetaxel as neoadjuvant treatment has shown promising clinical benefit and acceptable safety for pts with HER2+ early or LABC.
Secondary therapy:
docetaxel
Trial ID:
Source:
Title:
418P - Two-year follow-up data on the efficacy and safety of KN026, a HER2-targeted bispecific antibody combined with docetaxel as first-line treatment for HER2-positive recurrent/metastatic breast cancer
Published date:
10/16/2023
Excerpt:
KN026 in combination with docetaxel is well tolerated and has shown promising clinical benefit as 1L treatment for HER2-positive BC. After 2 years follow-up, mPFS was 25.4m and the 30-m OS rate was 83.7%, which is very promising.
Secondary therapy:
docetaxel
Trial ID:
Source:
Title:
KN026 in combination with docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer: A single arm, multicenter, phase 2 study
Published date:
11/22/2022
Excerpt:
...Of the 10 patients who completed surgery, tpCR rate were 50% (5/10, 95% CI: 18.7%-81.3%), bpCR rate were 50% (5/10, 95% CI:18.7%-81.3%), and ORR were 100% (10/10, 95% CI: 69.2%-100%)...KN026 and docetaxel as neoadjuvant treatment has shown promising clinical benefit for patients with HER2-positive early or locally advanced breast cancer with an acceptable and manageable safety profile.
Secondary therapy:
docetaxel
Trial ID:
Source:
Title:
PD18-08 Efficacy and safety results of KN026, a HER2-targeted bispecific antibody combined with docetaxel in first-line treatment of HER2-positive recurrent/metastatic breast cancer
Published date:
11/22/2022
Excerpt:
The confirmed ORR within 55 evaluable subjects was 76.4% (95% CI: 62.98, 86.77) and DoR was 18.1 months (95% CI: 12.45, NE). Median PFS was 19.3 months (95% CI: 13.86, NE)...The 12-, and 18-month OS rates were 93.5% (95% CI: 80.79, 97.89), and 88.3% (95% CI: 68.93, 95.92), respectively....KN026 in combination with docetaxel is well tolerated and has shown promising clinical benefit as a 1L treatment for HER2-positive advanced breast cancer.
Secondary therapy:
docetaxel
Source:
Title:
Preliminary safety, efficacy and pharmacokinetics (PK) results of KN026, a HER2 bispecific antibody in patients (pts) with HER2-positive metastatic breast cancer.
Published date:
05/13/2020
Excerpt:
KN026 is well tolerated and has demonstrated encouraging anti-tumor activity in HER2-positive breast cancer patients who have failed standard anti-HER2 therapies.
DOI:
10.1200/JCO.2020.38.15_suppl.1041
Trial ID:
Source:
Title:
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
Excerpt:
Female patients with HER2 positive MBC who had progressed on prior anti HER2 therapies received intravenous KN026 monotherapy...KN026, a HER2 bispecific antibody, was well tolerated and achieved comparable efficacy as trastuzumab and pertuzumab doublet even in the more heavily pretreated patients.
DOI:
10.1158/1078-0432.CCR-21-2827
