SABCS 2021 Meeting News Preview - 5

Fc region engineered to improve
immune engagement1
MARGENZA is an Fc-engineered monoclonal antibody that targets HER2+ cells1-3
* The Fc region of MARGENZA is purposely distinct from trastuzumab in that it has 5 specific mutations
engineered to improve immune engagement via increased binding to activating Fc receptors (CD16A)
and decreased binding to inhibitory Fc receptors (CD32B) in vitro
The clinical relevance of in vitro data is unknown.
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.
CD = cluster of differentiation; Fc = fragment crystallizable; HER2+ = human epidermal growth factor receptor 2 positive.
* Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function
prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
* Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for
effective contraception.
Left Ventricular Dysfunction
* Left ventricular cardiac dysfunction can occur with MARGENZA.
* In SOPHIA, left ventricular dysfunction occurred in 1.9% of
patients treated with MARGENZA.
* MARGENZA has not been studied in patients with a
pretreatment LVEF value of <50%, a prior history of myocardial
infarction or unstable angina within 6 months, or congestive
heart failure NYHA class II-IV.
* Withhold MARGENZA for ≥16% absolute decrease in LVEF
from pretreatment values or LVEF below institutional limits
of normal (or 50% if no limits available) and ≥10% absolute
decrease in LVEF from pretreatment values.
* Permanently discontinue MARGENZA if LVEF decline persists
greater than 8 weeks, or dosing is interrupted more than
3 times due to LVEF decline.
* Evaluate cardiac function within 4 weeks prior to and every
3 months during and upon completion of treatment. Conduct
thorough cardiac assessment, including history, physical
examination, and determination of LVEF by echocardiogram
or MUGA scan.
* Monitor cardiac function every 4 weeks if MARGENZA is
withheld for significant left ventricular cardiac dysfunction.
Embryo-Fetal Toxicity
* Based on findings in animals and mechanism of action,
MARGENZA can cause fetal harm when administered to a
pregnant woman. Post-marketing studies of other HER2 directed
antibodies during pregnancy resulted in cases of oligohydramnios
and oligohydramnios sequence manifesting as pulmonary
hypoplasia, skeletal abnormalities, and neonatal death.
* Verify pregnancy status of women of reproductive potential
prior to initiation of MARGENZA.
* Advise pregnant women and women of reproductive potential
that exposure to MARGENZA during pregnancy or within
4 months prior to conception can result in fetal harm.
References: 1. MARGENZA Prescribing Information. MacroGenics, Inc.;
2020. 2. Nordstrom JL, Gorlatov S, Zhang W, et al. Anti-tumor activity and
toxicokinetics analysis of MGAH22, an anti-HER2 monoclonal antibody
with enhanced Fcγ receptor binding properties. Breast Cancer Res.
2011;13(6):R123. doi:10.1186/bcr3069. 3. Rugo HS, Im S, Cardoso F, et al.
Efficacy of margetuximab vs trastuzumab in patients with pretreated ERBB2positive
advanced breast cancer: a phase 3 randomized clinical trial. JAMA
Oncol. Published online January 22, 2021. doi:10.1001/jamaoncol.2020.7932.
MARGENZA is a registered trademark of MacroGenics, Inc.
©2021 MacroGenics, Inc. All Rights Reserved. 10/2021 US-COM-MGA-2100140
Embryo-Fetal Toxicity (cont'd)
* Advise women of reproductive potential to use effective
contraception during treatment and for 4 months following
the last dose of MARGENZA.
Infusion-Related Reactions (IRRs)
* MARGENZA can cause IRRs. Symptoms may include fever,
chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting,
headache, diaphoresis, tachycardia, hypotension, pruritus,
rash, urticaria, and dyspnea.
* In SOPHIA, IRRs were reported by 13% of patients on
MARGENZA plus chemotherapy. Most of the IRRs occur
during Cycle 1. Grade 3 IRRs were reported in 1.5% of
MARGENZA-treated patients.
* Monitor patients during and after MARGENZA infusion.
Have medications and emergency equipment to treat IRRs
available for immediate use.
* In patients experiencing mild or moderate IRRs, decrease
rate of infusion and consider premedications, including
antihistamines, corticosteroids, and antipyretics. Monitor
patients until symptoms completely resolve.
* Interrupt MARGENZA infusion in patients experiencing
dyspnea or clinically significant hypotension and intervene
with supportive medical therapy as needed. Permanently
discontinue MARGENZA in all patients with severe or
life-threatening IRRs.
The most common adverse drug reactions (>10%) with MARGENZA
in combination with chemotherapy are fatigue/asthenia (57%),
nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%),
headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%),
peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%),
decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%),
palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).
You may report side effects to the FDA at (800) FDA-1088 or or to MacroGenics at (844)-MED-MGNX
Please see accompanying brief summary of full Prescribing
Information, including Boxed Warning.
J-code is J9353

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