Drug updated on 5/17/2024
| Dosage Form | Injection (intravenous; 250 mg/10 mL [25 mg/mL]) |
| Drug Class | HER2/neu receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with chemotherapy, 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-cmkb (Margenza) is indicated in combination with chemotherapy 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.
- Two randomized controlled studies were reviewed to gather information about Margenza's safety and effectiveness compared to trastuzumab in treating this patient population.
- The overall survival analysis did not show a significant advantage of Margenza over trastuzumab. However, a subgroup exploratory analysis showed potential improved overall survival for Margenza in patients with the CD16A-158FF genotype.
- A significant improvement was observed in progression-free survival among patients receiving Margenza compared to those on trastuzumab. This indicates that despite similar overall survival rates, there may be benefits associated with using margetuximab-cmkb (Margenza).
- Objective response rate also improved with the use of margetuximab-cmkb (Margenza), indicating a more favorable response regarding tumor reduction as opposed to its counterpart drug.
- The safety profile between both medications appears comparable; however, it should be noted that there is a higher incidence of infusion-related reactions reported during initial administration cycles with margetuximab-cmkb (Margenza).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Margenza (margetuximab-cmkb) Prescribing Information. | 2023 | 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 |
| The trastuzumab era: current and upcoming targeted HER2+ breast cancer therapies. | 2020 | American Journal of Cancer Research |