Drug updated on 4/16/2024
| Dosage Form | Injection (intravenous: 250 mg/10 mL [25 mg/mL]) |
| Drug Class | HER2/neu receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of adult patients with metastatic HER2- positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
Summary
- Margetuximab (Margenza) is indicated for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.
- The information about Margenza comes from a single document that is a Randomized Controlled Trial.
- In this trial, 536 patients were randomly assigned to receive either margetuximab plus chemotherapy or trastuzumab plus chemotherapy.
- The primary endpoints in this study were progression-free survival and overall survival (OS). Final OS analysis showed no significant advantage of margetuximab over trastuzumab; median OS was 21.6 months with margetuximab versus 21.9 months with trastuzumab.
- However, an exploratory analysis suggested possible improvement in OS for margetuximab in CD16A-158FF genotype patients compared to those receiving trastuzumab (median OS: 23.6 vs 19.2 months), while there might be an improvement in OS for CD16A -158VV genotype patients on Trastuzumub compared to those on Margeutxiumb (median Os:31 v/s22).
- Safety profile of Margeutxiumb (Margenza) was found comparable to Trasztusmub during the trials conducted as part of the study reviewed.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Margenza (margetuximab-cmkb) Prescribing Information. | 2020 | MacroGenics, Inc., Rockville, MD |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Margetuximab versus trastuzumab in patients with previously treated her2-positive advanced breast cancer (SOPHIA): final overall survival results from a randomized phase 3 trial. | 536Subjects F: 100% M: 0% | 2023 | Journal of Clinical Oncology |
| Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer A Phase 3 Randomized Clinical Trial. | 536Subjects F: 100% M: 0% | 2021 | JAMA Network |
| SOPHIA analysis by chemotherapy (Ctx) choice: A phase III (P3) study of margetuximab (M) + Ctx versus trastuzumab (T) + Ctx in patients (pts) with pretreated HER2+ metastatic (met) breast cancer (MBC). | 536Subjects F: 100% M: 0% | 2020 | Journal of Clinical Oncology |
Sex Distribution:
F:100%
M:0%
536Subjects
Year:
2023
Source:Journal of Clinical Oncology
Sex Distribution:
F:100%
M:0%
536Subjects
Year:
2021
Source:JAMA Network
Sex Distribution:
F:100%
M:0%
536Subjects
Year:
2020
Source:Journal of Clinical Oncology
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Systemic therapy for advanced human epidermal growth factor receptor 2–positive breast cancer: ASCO guideline update. | 2022 | Journal of Clinical Oncology |
| ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. | 2021 | Annals of Oncology |