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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Margenza (margetuximab-cmkb) (HER2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
12/16/2020
Excerpt:
MARGENZA is a HER2/neu receptor antagonist 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.
Secondary therapy:
Chemotherapy
Source:
Title:
Systemic Therapy for Advanced Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: ASCO Guideline Update
Published date:
05/31/2022
Excerpt:
If a patient's HER2-positive advanced breast cancer has progressed during or after second-line or greater HER2-targeted treatment...Recommendation…May offer margetuximab plus chemotherapy…
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.22.00519
Source:
Published date:
03/29/2021
Excerpt:
Invasive Breast Cancer: HER2-Positive - Other Recommended Regimens...Margetuximab-cmkb + capecitabine...Margetuximab-cmkb + Eribulin...Margetuximab-cmkb + gemcitabine...Margetuximab-cmkb + vinorelbine
Secondary therapy:
E7386; gemcitabine; vinorelbine; capecitabine
Source:
Title:
ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer
Excerpt:
HER2-positive breast cancer...Recommendations...Second-line treatment...Neratinib...and margetuximab...can be considered reasonable approaches in the late-line scenario.
DOI:
https://doi.org/10.1016/j.annonc.2021.09.019.
Source:
Title:
Safety and efficacy of monoclonal antibodies and tyrosine kinase inhibitors in advanced breast carcinoma.
Published date:
05/26/2022
Excerpt:
In a phase III trial comparing Margetuximab (MAR) vs Trastuzumab (TRA), the overall survival (OS) and Progression free survival (PFS) was superior for MAR (21.6m Vs 19.8m & 5.7m Vs 4.4m respectively)….Both monoclonal antibodies and tyrosine kinase inhibitors show clinically significant benefits in advanced HER2 positive breast carcinoma.
DOI:
10.1200/JCO.2022.40.16_suppl.e13017
Source:
Title:
Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer
Published date:
01/22/2021
Excerpt:
Margetuximab improved primary PFS over trastuzumab with 24% relative risk reduction (hazard ratio [HR], 0.76; 95% CI, 0.59-0.98; P = .03; median, 5.8 [95% CI, 5.5-7.0] months vs 4.9 [95% CI, 4.2-5.6] months...Margetuximab improved objective response rate over trastuzumab: 22% vs 16% (P = .06; October 10, 2018), and 25% vs 14% (P < .001...margetuximab plus chemotherapy had acceptable safety and a statistically significant improvement in PFS compared with trastuzumab plus chemotherapy in ERBB2-positive ABC after progression on 2 or more prior anti-ERBB2 therapies.
Secondary therapy:
gemcitabine + capecitabine + vinorelbine tartrate + E7386
DOI:
10.1001/jamaoncol.2020.7932
Trial ID:
Source:
Title:
Abstract GS1-02: Phase 3 SOPHIA study of margetuximab + chemotherapy vs trastuzumab + chemotherapy in patients with HER2+ metastatic breast cancer after prior anti-HER2 therapies: second interim overall survival analysis
Published date:
01/02/2020
Excerpt:
The intent-to-treat (ITT) population comprised 536 pts (M, 266; H, 270). M + chemotherapy prolonged PFS vs T + chemotherapy (median PFS, 5.8 vs 4.9 mo; hazard ratio [HR], 0.76; 95% confidence interval [CI]: 0.59-0.98; P=0.033)….M + chemotherapy in pts with treated HER2+ MBC improves PFS vs T.
DOI:
10.1158/1538-7445
Trial ID:
Source:
Title:
SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx).
Published date:
05/26/2019
Excerpt:
Pts were randomized 1:1 to M (15 mg/kg IV q3w + C)...M prolonged PFS over T (median 5.8 vs 4.9 mo, hazard ratio [HR], 0.76; 95% CI, 0.59–0.98; P= 0.033).In combination with chemotherapy in pretreated HER2+ MBC, M improves PFS over T with comparable safety.
Secondary therapy:
Chemotherapy
DOI:
10.1200/JCO.2019.37.15_suppl.100
Trial ID:
Source:
Title:
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (SOPHIA)
Excerpt:
...Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative...
Trial ID:
Source:
Title:
Complete response in patient with liver metastasis of HER2-positive breast cancer following therapy with margetuximab: a case report
Published date:
11/23/2022
Excerpt:
Here we present a case of a 67-year-old female patient who was diagnosed with HER2-positive, histological grade III and invasive ductal carcinoma of the left breast...The patient received eight cycles of second-line therapy (vinorelbine plus margetuximab) from January 2021. Since the ninth cycle, the patient was continued with only margetuximab. In March 2021, MRI showed a 70% decrease in the liver metastasis lesions. By June 2021, liver lesions were totally disappeared....This case demonstrates that margetuximab plus chemotherapy is safe and might bring clinical benefits for patients with HER2-positive breast cancer with liver metastasis.
Secondary therapy:
Chemotherapy
DOI:
10.1097/CAD.0000000000001466
