^
Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | anvatabart opadotin (JNJ-0683) (Microtubule inhibitor, HER2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
ACE-Breast-02 Pivotal Phase 3 Study of Ambrx’s ARX788 for the Treatment of HER2 Positive Metastatic Breast Cancer Achieves Positive Results
Published date:
03/01/2023
Excerpt:
Ambrx Biopharma Inc...announced today that it has been informed by its partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex), that an interim analysis for ACE-Breast-02, a randomized Phase 3 breast cancer clinical trial investigating Ambrx’s ARX788, an anti-HER2 antibody drug conjugate (ADC), has met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression free survival (PFS) benefit compared to the active control.
Source:
Title:
A clinical research study to test different doses of a study drug (ARX788), to see which dose is safest and its effectiveness(shrinks tumor size) in patients with advanced cancer. Estudio de investigación clínica para probar diferentes dosis del fármaco del estudio (ARX788), para ver qué dosis es la más segura y su efectividad (redución tamaño del tumor) en pacientes con cáncer avanzado.
Excerpt:
...Central laboratory-confirmed HER2-positive expression (estrogen receptor/progesterone receptor positive subjects may be enrolled if they are HER2-positive) according to 2018 American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) guidelines. ...
Trial ID:
Source:
Title:
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
Excerpt:
...- Her 2 Positive Metastatic breast cancer subjects previously treated with T-DXd...
Trial ID:
More C2 evidence
Source:
Title:
ARX788 in HER2-positive Breast Cancer Patients With Brain Metastases
Excerpt:
...- Breast cancer patients diagnosed as HR arbitrary/HER2-positive by pathological examination;...
Trial ID:
Source:
Title:
ARX788 in Breast Cancer With Low Expression of HER2
Excerpt:
...- Never had a HER2 positive result (IHC 3+ or FISH+) in previous pathological examinations;...
Trial ID:
Less C2 evidence
Source:
Title:
Phase 1 dose escalation study of ARX788, a next-generation anti-HER2 antibody drug conjugate, in heavily pretreated breast cancer patients
Published date:
12/02/2023
Excerpt:
ARX788-1711 (NCT03255070) was a phase 1 dose-escalation study of ARX788 monotherapy in pts with advanced solid tumors with HER2 expression….The disease control rate (confirmed complete or partial response + stable disease) was 81.8% and 76.7%, for HER2-pos and HER2-low BC, respectively. Six of 9 pts with confirmed responses had a duration of response greater than 5 months...
Trial ID:
Source:
Title:
PD18-09 ACE-Breast-03: Efficacy and safety of ARX788 in patients with HER2+ metastatic breast cancer previously treated with T-DM1
Published date:
11/22/2022
Excerpt:
ACE-Breast-03 (NCT04829604) is an ongoing global, phase 2, single-arm study evaluating ARX788 in patients with HER2+ mBC...The confirmed ORR was 57.1% (4/7 pts) and an unconfirmed ORR of 71.4% (5/7 pts) as one pt experienced an unconfirmed response with PR after 2 cycles. The disease control rate (DCR) was 100% (7/7 pts)…. In this small cohort of patients previously treated with T-DM1, ARX788 had a manageable AE profile and demonstrated promising clinical activity (confirmed ORR 57%; DCR 100%).
Trial ID:
Source:
Title:
Phase I Trial of a Novel Anti-HER2 Antibody-drug Conjugate, ARX788, for the Treatment of HER2-positive Metastatic Breast Cancer
Published date:
05/26/2022
Excerpt:
At 1.5 mg/kg Q3W, the recommended phase II dose, the objective response rate was 65.5% (19/29, 95% confidence interval [CI], 45.7-82.1), the disease control rate was 100% (95% CI, 81.2-100), and the median progression-free survival was 17.02 months (95% CI, 10.09 to not reached)....ARX788 demonstrated a manageable safety profile with promising preliminary signs of activity in HER2-positive MBC patients who progressed on prior anti-HER2 therapies.
DOI:
10.1158/1078-0432.CCR-22-0456
Source:
Title:
PD8-04: Safety and anti-tumor activity of ARX788 in HER2-positive metastatic breast cancer patients whose disease is resistant/refractory to HER2 targeted agents (trastuzumab, ADCs, TKIs, and bispecific antibodies): ACE-Breast-01 trial results
Published date:
10/09/2021
Excerpt:
Nineteen patients showed clinical response in the 1.5 mg/kg Q3W cohort, with the confirmed objective response rate of 66% (19/29, exact 95% CI, 45.7% to 82.1%), with median duration of response of 14.4 months [95% CI (9.0, NA)]. The disease control rate (CR + PR + SD) among the 29 patients treated was 100%....At the 1.5 mg/kg dose level, ARX788 had robust anti-tumor activity in patients whose disease was resistant/refractory to other HER2 targeted therapies and was generally well tolerated with low systemic toxicity.
Trial ID:
Source:
Title:
ARX788, a novel anti-HER2 antibody-drug conjugate, shows anti-tumor effects in preclinical models of trastuzumab emtansine-resistant HER2-positive breast cancer and gastric cancer
Published date:
03/31/2020
Excerpt:
ARX788 was effective in T-DM1-resistant in vitro and in vivo models of HER2-positive breast cancer and gastric cancer. ARX788 showed a pronounced growth inhibitory effect on all five HER2-positive cell lines tested, of which two gastric cancer cell lines had acquired resistance to T-DM1. ARX788 evoked more apoptotic events compared to T-DM1. Mice treated with ARX788 survived longer than those treated with T-DM1.
DOI:
10.1016/j.canlet.2019.12.037
