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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.

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Now Available

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.

See clinical results Learn More

The pivotal SOPHIA trial1

The efficacy of MARGENZA plus chemotherapy was evaluated in SOPHIA, a randomized, multicenter, open-label trial of 536 metastatic HER2-positive breast cancer patients* who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

MARGENZA plus chemotherapy reduced the risk of disease progression or death by 24% versus trastuzumab plus chemotherapy; hazard ratio=0.76 (95% confidence interval [CI], 0.59-0.98), P=0.033

  • Median progression-free survival (PFS): 5.8 months with MARGENZA plus chemotherapy compared with 4.9 months with trastuzumab plus chemotherapy

*IHC 3+ or ISH-amplified HER2+.

SOPHIA trial study design
SOPHIA trial study design

aThe median number of prior lines of therapy in the locally advanced/metastatic setting was 2 (range: 1-4). All study patients had previously received trastuzumab, all but 1 patient had previously received pertuzumab, and 91% had previously received ado-trastuzumab emtansine; 47% had visceral disease, 57% had bone metastases, 13% had brain metastases, and 60% were hormone receptor positive.

  • Patients were randomized (1:1) to MARGENZA plus chemotherapy or trastuzumab plus chemotherapy. Randomization was stratified by chemotherapy choice (capecitabine, eribulin, gemcitabine, or vinorelbine), number of lines of therapy in the metastatic setting (≤2, >2), and number of metastatic sites (≤2, >2)
  • Patients were required to have progressed on or after the most recent line of therapy. Prior radiotherapy and hormonal therapy were allowed
  • Patients were treated with MARGENZA or trastuzumab in combination with chemotherapy until disease progression or unacceptable toxicity
  • Patients received MARGENZA intravenously at a dose of 15 mg/kg every 3 weeks administered over 120 minutes for the initial administration and then over 30 to 120 minutes thereafter

See dosing and administration information

Efficacy results in SOPHIA

SOPHIA trial efficacy results

aAssessed per BICR.
bBased on Kaplan-Meier estimates.
cBased on stratified Cox Model.
dP-value based on 2-sided stratified log rank test.
CI: confidence interval; n: number of patients.

Kaplan-Meier curve for PFS in SOPHIA

Progression-free survival in SOPHIA

Safety of MARGENZA in combination with chemotherapy1

Adverse reactions (>10%) in patients with metastatic HER2+
breast cancer who received MARGENZA in SOPHIA

Safety of MARGENZA plus chemotherapy

aIncludes headache and migraine.
bIncludes abdominal pain, abdominal discomfort, lower abdominal pain, and upper abdominal pain.
cIncludes peripheral neuropathy, peripheral sensory neuropathy, peripheral motor neuropathy, and neuropathy.

Serious adverse reactions occurred in 16% of patients who received MARGENZA.

  • Serious adverse reactions in >1% of patients included febrile neutropenia (1.5%), neutropenia/neutrophil count decrease (1.5%), and infusion-related reactions (1.1%)
  • Fatal adverse reactions occurred in 1.1% of patients who received MARGENZA, including viral pneumonia (0.8%) and aspiration pneumonia (0.4%)

Permanent discontinuation due to an adverse reaction occurred in 3% of patients who received MARGENZA.

  • Adverse reactions that resulted in permanent discontinuation in >1% of patients who received MARGENZA included left ventricular dysfunction and infusion-related reactions
  • Dosage interruptions due to an adverse reaction occurred in 11% of patients who received MARGENZA. Adverse reactions that required dosage interruption in >5% of patients who received MARGENZA included infusion-related reactions
Reference:

1. MARGENZA Prescribing Information. MacroGenics, Inc.; 2020.

MARGENZA may be paired with a choice of 4 chemotherapy options1

In the SOPHIA trial, investigators were able to pair MARGENZA with a choice of 4 chemotherapy options, including capecitabine, eribulin, gemcitabine, and vinorelbine1

The recommended dose of MARGENZA is 15 mg/kg, administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.

  • Administer MARGENZA as an intravenous infusion at 15 mg/kg over 120 minutes for the initial dose, then over a minimum of 30 minutes every 3 weeks for all subsequent doses
  • On days when both MARGENZA and chemotherapy are to be administered, MARGENZA may be administered immediately after chemotherapy completion
  • If a patient misses a dose of MARGENZA, administer the scheduled dose as soon as possible. Adjust the administration schedule to maintain a 3-week interval between doses

Assess left ventricular ejection fraction (LVEF) before starting MARGENZA and regularly during treatment. Withhold MARGENZA dosing for at least 4 weeks for any of the following:

  • ≥16% absolute decrease in LVEF from pretreatment values
  • LVEF below institutional limits of normal (or 50% if no limits are available) and ≥10% absolute decrease in LVEF from pretreatment values

MARGENZA dosing may be resumed if, within 8 weeks, LVEF returns to normal limits and absolute decrease from baseline is ≤15%. Permanently discontinue MARGENZA if LVEF decline persists for greater than 8 weeks, or if dosing is interrupted on greater than 3 occasions for LVEF decline.

Infusion-Related Reactions (IRRs)

Decrease the rate of infusion for mild or moderate IRRs. Interrupt the infusion for dyspnea or clinically significant hypotension. Permanently discontinue MARGENZA dosing in patients with severe or life-threatening IRRs.

Reference:

1. MARGENZA Prescribing Information. MacroGenics, Inc.; 2020.

Supporting patient access to MARGENZA

MARGENZA Patient Support is here to help

Healthcare providers and prescribers can call 1-844-MED-MGNX to speak with a Case Manager who can assist with:

  • Ordering information
  • Billing and coding assistance
  • Reimbursement support
  • Details around the Patient Assistance Program and Copay Assistance Program

Additional Resources

Copay Assistance Enrollment Form

Download and then fax the completed form to enroll patients.

Patient Assistance Program Enrollment Form

Help for qualifying patients to obtain MARGENZA at no cost.

Billing and Coding Guide

Download for billing, coding, and reimbursement resource information.

Product distribution information

Authorized distributor Phone number
ASD Healthcare 800-746-6273
Cardinal Health Specialty Distribution 866-677-4844
McKesson Plasma and Biologics 877-625-2566
McKesson Specialty Health 800-482-6700
Oncology Supply 800-633-7555

MacroGenics does not recommend the use of one authorized distributor over another. MacroGenics does not make any warranty as to the services offered by any particular authorized distributor.

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IMPORTANT SAFETY INFORMATION

WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

  • 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.
WARNINGS & PRECAUTIONS:
Left Ventricular Dysfunction
  • Left ventricular cardiac dysfunction can occur 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.
  • 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.
  • 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.
MOST COMMON ADVERSE REACTIONS:

The most common adverse drug reactions (≥10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

INDICATION

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.

Please see full Prescribing Information, including Boxed Warning.